Business Process Procedure SD

165
SAP ECC 6.00 March 2007 English Solid Dosage Forms (P50) Part 1 Business Process Procedure

description

Business Process Procedure in SAP SD

Transcript of Business Process Procedure SD

Page 1: Business Process Procedure SD

SAP ECC 6.00

March 2007

English

Solid Dosage Forms (P50)Part 1

SAP AGDietmar-Hopp-Allee 1669190 Walldorf

Business Process Procedure

Page 2: Business Process Procedure SD

Germany

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Copyright

© Copyright 2007 SAP AG. All rights reserved.

No part of this publication may be reproduced or transmitted in any form or for any purpose without the express permission of SAP AG. The information contained herein may be changed without prior notice.

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SAP, R/3, mySAP, mySAP.com, xApps, xApp, SAP NetWeaver, and other SAP products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of SAP AG in Germany and in several other countries all over the world. All other product and service names mentioned are the trademarks of their respective companies. Data contained in this document serves informational purposes only. National product specifications may vary.

These materials are subject to change without notice. These materials are provided by SAP AG and its affiliated companies ("SAP Group") for informational purposes only, without representation or warranty of any kind, and SAP Group shall not be liable for errors or omissions with respect to the materials. The only warranties for SAP Group products and services are those that are set forth in the express warranty statements accompanying such products and services, if any. Nothing herein should be construed as constituting an additional warranty.

The Advanced Planning Board for mySAP ERP is a product of OR Soft Jaenicke GmbH based on SCHEDULE++. SCHEDULE++ is copyright 1990-2005 by OR Soft Jaenicke GmbH. The Plug-in YPORS* and all related components and documents are copyright 2004-2005 by OR Soft Jaenicke GmbH. The OR Soft Logo is a registered trademark of OR Soft Jaenicke GmbH.

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Icons

Icon Meaning

Caution

Example

Note

Recommendation

Syntax

Typographic Conventions

Type Style Description

Example text Words or characters that appear on the screen. These include field names, screen titles, pushbuttons as well as menu names, paths and options.

Cross-references to other documentation.

Example text Emphasized words or phrases in body text, titles of graphics and tables.

EXAMPLE TEXT Names of elements in the system. These include report names, program names, transaction codes, table names, and individual key words of a programming language, when surrounded by body text, for example, SELECT and INCLUDE.

Example text Screen output. This includes file and directory names and their paths, messages, source code, names of variables and parameters as well as names of installation, upgrade and database tools.

EXAMPLE TEXT Keys on the keyboard, for example, function keys (such as F2) or the ENTER key.

Example text Exact user entry. These are words or characters that you enter in the system exactly as they appear in the documentation.

<Example text> Variable user entry. Pointed brackets indicate that you replace these words and characters with appropriate entries.

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ContentsOverview........................................................................................................................................ 7

Flexible Planning (P64).................................................................................................................. 8

Data Source of Info Structure.....................................................................................................9

Create demo data using upload file..........................................................................................10

Generate planning hierarchy master data................................................................................10

Calculate proportional factors using actual data.......................................................................11

Reset Generation Time Stamp.................................................................................................12

Set Status of Background Job for Statistical Forecast.............................................................12

Check Sales History in Planning Type.....................................................................................13

Schedule Background Job for Statistical Forecast...................................................................14

Change Local Plan in Flexible Planning...................................................................................14

Schedule Planning Job for Fixing Local Plan...........................................................................15

Create Global Plan...................................................................................................................16

Schedule Planning job for fixing global plan and creation of consolidated sales data..............17

Schedule Planning job for transfer plan data to demand management....................................18

Production Planning (P08)...........................................................................................................19

Create or change planned independent requirements.............................................................20

MRP Run................................................................................................................................. 21

Convert Planned Order into Process Order..............................................................................22

Release Process Order............................................................................................................23

Capacity Planning (P44)..............................................................................................................25

Purpose.................................................................................................................................... 25

Process Flow............................................................................................................................ 26

Capacity Evaluation.................................................................................................................26

Capacity Leveling..................................................................................................................... 27

Advanced Planning Board for mySAP ERP (P63).......................................................................29

Purpose.................................................................................................................................... 29

Use........................................................................................................................................... 30

Prerequisites............................................................................................................................ 30

Procedure................................................................................................................................ 31

Result....................................................................................................................................... 32

Procurement of Stock Materials (P07).........................................................................................33

Purpose.................................................................................................................................... 33

Conversion of Purchase Requisitions (all materials)................................................................33

Goods receipt (not batch managed, without WM)....................................................................37

Goods receipt (batch managed, without WM)..........................................................................38

Goods receipt (batch managed, with WM)...............................................................................39

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Bin Stock per Material..............................................................................................................41

Invoice Verification................................................................................................................... 41

Automatic Payment Transactions / Payment Program.............................................................44

QM in Procurement (P18)............................................................................................................53

Purpose.................................................................................................................................... 53

Quality Inspection in Goods Receipt (without Sample Management).......................................53

Quality Inspection in Goods Receipt (with Sample Management)............................................55

Quality Inspection in Goods Receipt with Inspection Plan and Quality Info Record.................58

Recurring inspection with copy of inspection results................................................................59

WM Integration (P06)................................................................................................................... 61

Purpose.................................................................................................................................... 61

Transport order for Goods Receipt to Purchase Order............................................................61

Regulated Manufacturing (SAPyrin) (P09)...................................................................................64

Purpose.................................................................................................................................... 64

Creating and Releasing Process Orders..................................................................................64

Process Order Execution/ Process Management.....................................................................66

Process Manufacturing Cockpit (P14).........................................................................................71

HUM and Material Identification (P15).........................................................................................72

Purpose.................................................................................................................................... 72

Creation of Handling Units for Manufacturing...........................................................................72

Completeness Check and Sequence Check............................................................................72

Material Reconciliation (P16).......................................................................................................74

Purpose.................................................................................................................................... 74

Electronic Batch Record (P13).....................................................................................................75

Purpose.................................................................................................................................... 75

Setting inspection close in QM.................................................................................................75

Completing process order technically......................................................................................76

Generating batch record..........................................................................................................76

Archiving and approving batch record......................................................................................77

Integration of Weighing System (P12).........................................................................................79

Purpose.................................................................................................................................... 79

Creating Process Orders..........................................................................................................79

Sending Control Recipes.........................................................................................................80

Processing weighing orders at weighing system......................................................................81

Sending process messages (of weighing system)...................................................................81

Processing PI sheet................................................................................................................. 81

Sending process messages.....................................................................................................82

Batch Information Cockpit (P03)..................................................................................................83

Expiration Date Calculation (Batch derivation) (P17)...................................................................84

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Manual derivation..................................................................................................................... 84

Batch derivation during batch record generation......................................................................85

SAP OPC Data Access and Alert Management (P27).................................................................87

Selecting delivery type for alerts..............................................................................................87

Sending messages from PMC (manually)................................................................................88

Getting values from PCS and sending messages (automatically)............................................89

Subscribe values and generate messages automatically.........................................................91

Engineering Change Management (P41)....................................................................................93

Purpose.................................................................................................................................... 93

Create Change Request..........................................................................................................93

Check Change Request...........................................................................................................95

Approve Change Request and Convert it into a Change Order...............................................96

Perform Changes to Master Recipes and Bill of Materials.......................................................96

Assign Change Number to Production Version........................................................................97

Complete and Release Object Changes..................................................................................97

Close and Release Change Order...........................................................................................98

QM in Production (P32)...............................................................................................................99

Purpose.................................................................................................................................... 99

Production of Solid Dosage Forms - In-Process control (from PI sheet)..................................99

Production of Solid Dosage Forms - In-Process control.........................................................100

Production of Solid Dosage Forms - Post-Process control (with Sample Management)........103

Pharma Packing - Post-Process control.................................................................................107

WM Integration (P06)................................................................................................................. 110

Purpose.................................................................................................................................. 110

Staging Materials for Production............................................................................................110

Putaway from produced material............................................................................................113

Sales and Distribution (P20)......................................................................................................116

Purpose.................................................................................................................................. 116

Process Flow.......................................................................................................................... 116

Sales Order............................................................................................................................ 117

Shipping: Delivery (with WM).................................................................................................118

Warehouse Management: Transfer Order for Delivery (same quantity).................................119

Shipping: Delivery.................................................................................................................. 123

Goods Issue for Delivery........................................................................................................124

Billing..................................................................................................................................... 125

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Overview

SAP AG 2005, SAP Best Practices

Manufacturing of SAPyrin – Overview (1)

Dispensing, Granulation, Compression, Coating

Blistering

Batch productionRecipe MR-13001/1 (no ECM)Recipe MR-13011/1 (with ECM)

Batch productionRecipe MR-12001/1(no ECM)Recipe MR-12002/1(Weighing System)Recipe MR-12011/1(with ECM)

Plant BP01

Cornstarch

ROH

PH-1610

AcetylSalicylic Acid

HALB

PH-2400

Active ingredient production

Batch productionRecipe MR-11001/1 (no ECM)Recipe MR-11011/1 (with ECM)

Salicylic Acid

ROH

PH-1520

Acetic Anhydrid

ROH

PH-1510

Aspartam

ROH

PH-1630Cellulose Powder

ROH

PH-1620

SAPyrin Blister

HALB

PH-2600

SAPyrin Tablet

HALB

PH-2500

Polymer CoatingSolution

ROH

PH-1640

Blister Foil

YPPM

PH-4100

Description

Mat type

Mat Nr

WM managed

QM active Batch managed

Aluminium Foil

YPPM

PH-4200

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SAP AG 2005, SAP Best Practices

Manufacturing of SAPyrin – Overview (2)

Packaging

SAPyrin Blister

HALB

PH-2600Box SAPyrin

YPPM

PH-4501Leaflet SAPyrin

YPPM

PH-4910

SAPyrin protect(20 Pcs.)

FERT

PH-6501Plant BP01

Recipe MR-14002/1Recipe MR-14012/1

Recipe MR-14003/1Recipe MR-14013/1

Recipe MR-14004/1Recipe MR-14014/1

andand

SAPyrin protect(50 Pcs.)

FERT

PH-6502

SAPyrin protect(10x50 Clinical)

FERT

PH-6504

SAPyrin protect(Doc. Sample)

FERT

PH-6503

Box SAPyrin

YPPM

PH-4502Box SAPyrin

YPPM

PH-4503Box SAPyrin

YPPM

PH-4504

Batch productionRecipe MR-14001/1 (no ECM)Recipe MR-14011/1 (with ECM)

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Flexible Planning (P64)

Be advised that flexible planning leads to automatic creation of planned independent requirements. If Building Block P64 is not used proceed with the following chapter Production Planning (P08), where planned independent requirements will be created manually.

Overview scenario flexible planningFlexible Planning offers multiple options for customized configuration: you can plan on any organizational level, and also define the content and the layout of the planning screens.

You can process your planning data from the standpoint of almost any organizational unit (for example, sales organization, material group, production plant, product group, material) and even from the standpoint of the entire enterprise.

The planning table in which you work resembles a spreadsheet. You have enormous scope to track previous planning data, anticipate market demand, run analyses, and perform what-if simulations. A series of mass processing functions automate the planning of large volumes of data.

The maintained best practice process consists of a two-level planning approach. On the first level a local planner is able to enter a monthly sales quantity in the local sales plan. The sales data of the past and a calculated forecast is available for the local planner to give some advice for estimating the sales quantities.

On the second level a global planner is able to do a delta-correction and a review on the consolidated local plan data. The sales data of the past and the forecast data are also displayed in the global plan. The reviewed plan will be transferred to the Sales & Operations Planning to further create a rough-cut production plan based on the sales plan.

Planning calendarThe time table for each planning cycle in the maintained best practice process is 10 working days. The planning calendar shows the planning activities including actions and corresponding roles.

Day Activity Action Role

1. Setup - Schedule Copy Management (S003 S995 Billing quantity for flexible planning)

- Generate planning hierarchy master data

- Calculate proportional factors using actual data

Technical Support

2. Correction/ Forecast Schedule Background Job for statistical Forecast

3.-6. Local Planning Determine sales data in local plan Local Planner

6.-7. Fixing local sales plan

Schedule Planning Job for fixing local plan

Technical Support

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Day Activity Action Role

7.-9. Global Planning Delta-correction on local plan data within global plan

Global Planner

9. -10. Fixing global sales plan

Schedule Planning job for fixing global plan and creation of consolidated sales data

Technical Support

10. Transfer Schedule Transfer job to Demand Management

Data Source of Info Structure

Schedule Copy Management S003S995

UseIn the Flexible Planning scenario the sales history data is copied from the standard information structure S003 to the information structure S995 for flexible planning.

If there is sales data so far in information structure S003 in the specified SAP system you can use the Copy Management to copy the relevant sales data from information structure S003 to S995.

Since you need at least sales history of one year to calculate a reasonable statistical forecast a demo upload program is also available to create demo sales history in your system. If you have no sales history so far in the information structure S003 skip this step and continue with the next step Create demo data using upload file.

Procedure1. Access the activity using one of the following navigation options:

IMG Menu Logistics – General Logistics Information System (LIS) Logistics Data Warehouse Data Basis Tools Copy Management

Transaction Code MCSZ

2. On the LIS Copy Management: Initial Screen make the following entry and choose Enter

Key field Entry

Source info struct. S003

3. On the LIS Copy Management: Work Table screen choose Direct Execute (F8).

4. On the LIS Copy Management: Function Selection screen choose Continue (Enter).

5. On the screen Editing Statistical Data in Info Structure S003 choose Get Variant (Shift + F5).

6. On the upcoming screen ABAP: Variant Directory of Program RMCA0035 choose variant name YQ_000000 and Execute (F8).

7. Confirm the information that a specified number of records were converted.

8. Confirm the next information that a specified number data records were not copied/converted.

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ResultThe relevant sales data from information structure S003 was copied to S995.

Create demo data using upload file

UseIf there is no sales data so far in info structure S003 in the specified SAP System you can use the following report to upload example sales data from an external file into the information structure S995 for demo purposes in the scenario flexible planning.

Procedure1. Access the transaction choosing one of the following navigation options:

SAP menu Tools ABAP Workbench Development ABAP Editor

Transaction code SE38 resp. SA38

2. On the screen ABAP Editor: Initial Screen make the following entry and choose Execute.

Key field Entry

Program ZYP_FILL_S995

3. On the screen Fill Information Structure with data from Excel Sheet choose F4.

4. On the Open File Dialog screen choose the file for example data Simulation_data_s995.TXT from the HTML-DVD (Path: Misc \Pharmaceuticals \Global \Planning).

5. Choose Execute (F8). Confirm upcoming information message with Yes.

ResultThe report ZYP_FILL_S995 was executed and the (simulated) historical sales data is now uploaded into info structure S995.

Generate planning hierarchy master data

UseThis step is needed to generate the characteristic combinations which will be used in the flexible planning. This can also be done manually. In this scenario the planning hierarchy will be generated by the system. The basis for the generation of the planning hierarchy will be the sales history data which is stored in the information structure S995.

Procedure1. Access the transaction choosing one of the following navigation options:

SAP menu Logistics Production SOP Planning Flexible Planning Master Data Generate Master Data

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Transaction code MC9A

2. On the screen Set Up Planning Hierarchy / Master Data Based on Planned / Actual Version make the following entries and choose Execute (F8).

Key field Entry

Info structure S995

Version 000

Simulation Indicator Flag not set (delete flag)

Period from two years back from current date

Period to current date

ResultThe planning hierarchy for info structure S995 was generated.

Calculate proportional factors using actual data

UseThe scenario step is needed to calculate the proportional factors. These factors will be used to disaggregate the planning data to the lower levels with the correct proportions. The basis for the calculation of the proportional factors will be the billed quantities in the past, which are stored in the information structure S995.

Procedure1. Access the transaction choosing one of the following navigation options:

SAP menu Logistics Production SOP Planning Flexible Planning Master Data Planning Hierarchy Calculate proportional factors Using actual data

Transaction code MC8U

2. On the Calculate Proportions for Info structure screen make the following entries and choose Enter.

Key field Entry

Info structure S995

Consistent Planning: Adjust plng. Hierarchy proportions

Set Flag

3. On the upcoming Source Info structure screen make the following entries and choose Enter.

Key field Entry

Info structure S995

Version 000

from two years back from current date

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Key field Entry

to current date

4. On the upcoming screen Key Figure select Billing quantity and choose Enter.

5. The message Proportional factors successfully calculated is displayed.

ResultThe proportional factors are calculated.

Reset Generation Time Stamp

UseThe purpose of this activity is to reset generation time stamps for all planning relevant programs and screens.

Procedure1. Access the transaction choosing one of the following navigation options:

IMG menu Logistics-General Logistics Information System (LIS) Planning Tools Planning Reset generation time stamp

Transaction code MCSY

2. On the Program to Reset Generation Time Stamp screen make following entries:

Key field Entry

Program for planning flag set

Screen for planning flag set

Progrm for background planning

flag set

3. Choose Execute.

ResultThe generation time stamps were reset.

Set Status of Background Job for Statistical Forecast

UseThe purpose of this activity is to reset status for further activities.

Procedure1. Access the transaction choosing one of the following navigation options:

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SAP menu Logistics Production SOP Planning Flexible Planning Planning Mass Processing Change

Transaction code MC8E

2. On the Change Background Run screen make the following entries and choose Execute.

Key field Entry

Job number 1

3. Choose Reset and accept upcoming information message.

4. To make sure that screen are generated re-enter transaction mc8e and choose Execute on the Change Background Run screen in order to get to the Maintain Variant: Report XXXXXXXX screen.

5. Repeat step 2-4 for all existing job numbers (2, 3, 4).

ResultThe status of background job was reset.

Check Sales History in Planning Type

UseThe purpose of this activity is to check availability of the sales history which is imported from an external file during installation.

Procedure1. Access the transaction choosing one of the following navigation options:

SAP menu Logistics Production SOP Planning Flexible Planning Planning Change

Transaction code MC94

2. On the Change Plan in Flexible Planning: Initial Screen make the following entries and choose Enter.

Key field Entry

Planning type YP_BATCH

3. On the Planning for info structure S995 screen make sure that all selection fields are empty and choose Active version.

4. On the Change Plan (Consistent Planning) screen make sure that entries are available in the line Actual Billing quantity for the last 12 months.

ResultThe availability of historical data was checked.

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Schedule Background Job for Statistical Forecast

UseThe scenario flexible planning includes the calculation of the statistical forecast.

Procedure1. Access the transaction choosing one of the following navigation options:

SAP menu Logistics Production SOP Planning Flexible Planning Planning Mass Processing Schedule

Transaction code MC8G

2. On the screen Schedule Background Run for Selected Planning Objects make the following entries and choose Execute (F8).

Key field Entry

Job number 1

Bkgrnd plng. runCALCULATE STATISTICAL FORECAST(can not be changed)

3. On the upcoming screen Start Time select Immediate and choose Save.

ResultThe background job to calculate the statistical Forecast is executed.

The execution of background jobs and job logs can be reviewed in transaction sm37.

Change Local Plan in Flexible Planning

UseThis step of the scenario is used to create/change a local demand plan. The local planner will forecast the estimated quantity in the planning grid. In order to make the decision easier a statistical forecast and sales history of the last months will be provided in the planning grid.

Procedure1. Access the transaction choosing one of the following navigation options:

SAP menu Logistics Production SOP Planning Flexible Planning Planning Change

Transaction code MC94

2. On the screen Change Plan in Consistent Planning: Initial screen make the following entries and choose Enter.

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Key field Entry

Planning type YP_LOCAL

3. On the screen Planning for info structure S995 make the following entries and select Active version.

Key field Entry

Sales Organization BP01

Distribution Channel 01

Division 01

Material PH-6501 or PH-6502 or PH-6503 or PH-6504

4. On the screen Change Plan (Consistent Planning) the local planner can modify the monthly displayed data in the key figure Local Planning for the selected material in corresponding sales organization, distribution channel and division.

Key field M <current month+1.year>

Local Planning (KG) 5000 (as an example)

5. The plan can switched e.g. from detailed information for the actual material including also sold-to-party to subtotaled information and further to aggregate information.

6. Choose Save.

ResultThe local planner has modified the amount of the proposed local sales quantity in the local plan for the entered material.

Schedule Planning Job for Fixing Local Plan

UseAfter closing the local plan for modifying local planning data the local plan needs to be fixed. The fixing for local plan data is executed by using a background job.

Procedure1. Access the transaction choosing one of the following navigation options:

SAP menu Logistics Production SOP Planning Flexible Planning Planning Mass Processing Schedule

Transaction code MC8G

2. On the screen Schedule Background Run for Selected Planning Objects make the following entries and choose Execute (F8).

Key field Entry

Job number 2

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Key field Entry

Bkgrnd plng. run COPY LOCALPLAN LOCAL FIX(can not be changed)

3. On the upcoming screen Start Time select Immediate and choose Save.

ResultThe background job to fix the local plan is executed.

The execution of background jobs and job logs can be reviewed in transaction sm37.

Create Global Plan

UseIn the next step of the scenario flexible planning the sales data in the global plan is corrected and reviewed for example by a global planner.

Procedure1. Access the transaction choosing one of the following navigation options:

SAP menu Logistics Production SOP Planning Flexible Planning Planning Change

Transaction code MC94

2. On the screen Change Plan in Consistent Planning: Initial screen make the following entries and choose Enter.

Key field Entry

Planning type YP_GLOBAL

3. On the screen Planning for info structure S999 make the following entries and select Active version.

Key field Entry

Sales Organization BP01

Distribution Channel 01

Division 01

Material PH-6501 or PH-6502 or PH-6503 or PH-6504(use the same material as for local plan)

4. On the screen Change Plan (Consistent Planning) the global planner can modify the monthly displayed data in the key figure Global Planning for the selected material in e.g. corresponding sales organization, distribution channel and division.

5. The following examples show the correction of the sales data.

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Key field Entry Correction

Global Planning -1000 Decreases sales data of 1000

Global Planning 8000 Increases sales data of 8000

6. Choose Save.

7. In order to get more detailed information (e.g. planning on customer level) choose Details and Key figure.

The key figure Transfer to SOP in the global plan will be used in the next step to keep the consolidated sales data.

ResultThe global planner has e.g. modified the amount of the proposed local sales quantity in the global plan.

Schedule Planning job for fixing global plan and creation of consolidated sales data

UseAfter closing the global plan for modifying sales data the global plan needs to be fixed. The fixing for the global plan data and the addition of amounts of local and global plan to create consolidated sales data is executed by using a background job.

Procedure1. Access the transaction choosing one of the following navigation options:

SAP menu Logistics Production SOP Planning Flexible Planning Planning Mass Processing Schedule

Transaction code MC8G

2. On the screen Schedule Background Run for Selected Planning Objects make the following entries and choose Execute (F8).

Key field Entry

Job number 3

Bkgrnd plng. run COPY GLOBALPLAN GLOBAL FIX(can not be changed)

3. On the upcoming screen Start Time select Immediate and choose Save.

ResultThe Background job to copy the data of the global plan to fixed global plan data and the consolidation of sales data is executed.

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The execution of background jobs and job logs can be reviewed in transaction sm37.

Schedule Planning job for transfer plan data to demand management

UseAfter the execution of all planning steps the plan will be transferred as independent requirements to the active operative environment. With this step you transform data which is so far save in an information structure to real orders in your SAP system.

Procedure1. Access the transaction choosing one of the following navigation options:

SAP menu Logistics Production SOP Planning Flexible Planning Planning Mass Processing Schedule

Transaction code MC8G

2. On the screen Schedule Background Run for Selected Planning Objects make the following entries and choose Execute (F8).

Key field Entry

Job number 4

Bkgrnd plng. run TRANSFER TO DEMAND MANAGEMENT(can not be changed)

3. On the upcoming screen Start Time select Immediate and choose Save.

ResultThe Background job to copy the data from the flexible planning to the demand management is executed.

The execution of background jobs and job logs can be reviewed in transaction sm37.

The transferred quantities to the demand management can be reviewed in transaction md61.

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Production Planning (P08)

PurposeThe material requirements planning scenario is used to create a one-year planning basis for a material. On the basis of planned independent requirements and depending on warehouse stocks, planned orders (for production) or purchase requisitions (for purchasing) are created across all BOM levels.

To carry out the planning run, planned independent quantities must exist, and a strategy group must be allocated to the materials.

Material Material description Plant StrategyUseful monthly

quantityMRP

controller

PH-6501 SAPyrin (20 tablets) BP01 40 240000 EA 400

PH-6502 SAPyrin (50 tablets) BP01 40 96000 EA 400

PH-6503SAPyrin (20 tablets, Doctor's sample)

BP01 40 60000 EA 400

PH-6504SAPyrin (10x50 tablets, clinical)

BP01 40 15000 EA 400

Process FlowMaterial requirements planning is carried out in two steps:

1. Create planned independent requirements

2. Carry out planning run

Material requirements planning is controlled by means of the planning strategies. For Cetepharm the following planning strategy is used:

Planning strategy 40

In this strategy, the sales orders are included in the production program. Production, including packaging, should, however, be triggered by planned independent requirements before the sales orders are received. As soon as the sales order is received, it is calculated with the planned independent requirement. This enables you to compare planning and the actual customer requirements. Additional demand, which occurs when sales order quantities exceed the planned independent requirement quantities, increases the production quantities involved.

The planned independent requirements are entered at the finished product level. This triggers the procurement of raw materials and the production of the required intermediate products. Inbound sales orders are calculated with the planned independent requirements. Planned independent requirement quantities that have not been exhausted increase the warehouse stock of the finished products. If the sales orders exceed the planned quantities, these over demands cause the production plan to be adjusted automatically.

Customer requirements are allocated dynamically to planned requirements; in other words, when sales orders are rescheduled, the allocation is terminated and respecified.

Planning- and Stock level: Finished product

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ResultThe material requirements planning allows to plan all requirements for one plant (production and procurement) in advance.

Create or change planned independent requirements

If Flexible Planning (P64) was used for creation of planned independent requirements automatically proceed with transaction md62.

UsePlanned independent requirements serve as preliminary planning for all BOM levels. They display the expected quantities from sales orders.

PrerequisitesTo create planned independent requirements a strategy group must be assigned to the materials.

Procedure1. Access the transaction using:

Menu Logistics Production – Process Production Planning Demand Management Planned Independent Requirements Create/Change

Transaction code MD61 / MD62

2. On the Planned independent requirements screen, enter the necessary data.

Field name Description User action and values Comment

Material number

PH-6501 and PH-6502, PH-6503,PH-6504

Plant BP01

Version 00 Actual req. plan

Planning horizon

1 year

Planning period

M Month

3. Choose Execute and you get to the Create independent requirements/ planning table screen.

Field name Description User action and values Comment

Planned quantity

Enter monthly quantities See overview table for quantities

4. Save your entry.

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ResultFor the finished goods PH-6501, PH-6502, PH-6503 and PH-6504 preliminary planning requirements for one year, split into months, were created.

MRP Run

PurposeUsually the MRP run is performed daily. The run compiles the requirements from the independent planned requirements, the individual sales requirements, already existing planned orders and available stock.

The planning is performed on the finished product. All BOM items of the materials are planned.

PrerequisitesRequirement changes are made (sales order, independent planned requirements); the MRP type PD must be entered in the material master.

Before starting MRP check the planning file entries (combinations of materials and plant) using transaction md21.

Procedure1. Access the transaction using:

Menu Logistics Production – Process MRP Planning Total Planning Single-Item, Multi-Level Planning

Transaction code MD02

2. On the Materials Requirements planning screen, enter the necessary data.

Field name Description User action and values Comment

Material PH-6501 and PH-6502, PH-6503,PH-6504

Plant BP01

Processing key

NETCH Net change for total horizon

Create pur. req

2 Purchase requisitions in opening period

Delivery schedules

3 schedule lines

Create MRP list

1 MRP list

Planning mode

2 Re-explode BOM and routing

Scheduling 2 Lead time scheduling and capacity planning

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Display material list

Indicator set

Settings Save Only necessary at the first time

3. Choose Enter three times!

ResultFor plant BP01 materials PH-6501, PH-6502, PH-6503 and PH-6504 are planned based on the existing materials. Planned orders and/or purchase requisitions are created. Exploding the BOM ensures that all BOM levels are included in the plan.

Convert Planned Order into Process Order

UseDuring process planning, the planned orders are converted to process orders, whereby the basic dates and quantities are copied and used as a basis to determine concrete production dates. Dates and quantities can also be adapted manually.

PrerequisitesA planned order must be created.

Procedure1. Access the transaction using:

Menu path Logistics Material Management Inventory Management Environment Stock Stock/Reqmts List

Transaction code MD04

2. Enter the required data on the Stock/Reqmts List/Initial Screen.

Field name Description User action and values Comment

Material PH-6501 or PH-6502, PH-6503,PH-6504

Plant BP01

3. Choose Enter.

4. On the Stock/Requirements List as of XX:XX screen choose a line with planned order.

Field name Description User action and values Comment

Position cursor on corresponding line

Double-click line or PH-6502, PH-6503,PH-6504

> Process order

Choose Convert planned order into process order

Alternatively Ctrl.+F2

5. The Create Process order: Initial Screen (transaction: cor7) opens.

6. Confirm the message Master recipe XXXXXX does not require approval with Enter.

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In the pharmaceutical industry, master recipes, that are subject to approval as well as process orders, that are subject to individual approval are used. This is a prerequisite for the electronic batch record EBR (Building Block P13).

The master recipes that are used to manufacture above materials are not subject to approval, even though this is required by the used process order type YP01. For this reason, the system expects an individual approval for the order release and the acceptance of the information message.

7. On the Create Process Order: Header – General Data screen choose from menu Process order Functions Approval Individual approval.

8. Save the process order.

ResultWhen the process order is created, material reservations for the components are created.

Release Process Order

UseTo start production and print the production documents it is necessary to release the process order.

PrerequisitesA process order must be created and all materials must be available.

Procedure1. Access the transaction using:

Menu path Logistics Material Management Inventory Management Environment Stock Stock/Reqmts List

Transaction code MD04

2. Enter the required data on the Stock/Reqmts List/Initial Screen.

Field name Description User action and values Comment

Material PH-6501 or PH-6502, PH-6503,PH-6504

Plant BP01

3. Choose Enter.

4. Select the process order to be released using Add. data for element.

5. On the Additional data for MRP element screen choose Change element (F8)

6. The Change Process order: Header – General Data screen opens (transaction cor2).

7. Choose Release and save the process order.

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ResultThe availability of the materials is checked again. Batch determination is carried out automatically for the materials. In addition to this, the control recipes are created, a preliminary costing and the process instructions are generated. Confirmations are possible at this point.

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Capacity Planning (P44)

PurposeThe capacity planning can be used to support different phases of production planning. The following scenario gives an overview of basic functionality and comprises the following parts:

Capacity evaluation to analyze capacity loads (mid-term planning)

In the capacity evaluation on single resources, available capacity and capacity requirements are determined and compared with each other in lists or graphics. You can use resource hierarchies to cumulate the available capacities of production resources and their capacity requirements to superior planning work centers.

Capacity leveling (detailed scheduling)

With capacity leveling the optimal capacity commitment for the resources has to be found. Therefore two types of planning tables (graphical and tabular versions) can be used to display the capacity situation and to carry out capacity leveling. Dispatching operations is the main function of capacity leveling. Operations are dispatched to the time when there is sufficient capacity on the resource for them to be executed.

Available Capacities

The available capacities are maintained at a resource using different capacity categories like a machine capacity or a labor capacity. For every capacity assigned to a resource you can maintain a standard available capacity with unrestricted temporal validity and additional versions. To use more detailed available capacities shift definitions and sequences can be used.

The standard available capacity is determined by:

Work start and work finish

Length of breaks

Rate of capacity utilization

Number of individual capacities which the capacity consists of.

Capacity Requirements

Orders generate capacity requirements and thus a load on the resources that are to process them. In the following scenario process orders and planned orders are considered.

Calculating the capacity requirements of an operation for manufacturing a material takes place in scheduling using formulas from the resource. For this, a formula is entered to calculate the capacity requirements of the operations on the screen Capacity overview. The formulas which you can maintain in Customizing contain formula parameters like standard values from the operation or work center constants. The formula can be checked on the Capacities tab page for each resource.

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Result

After carrying out capacity planning on mid-term planning level individual resources are checked for overloads and if necessary planned orders are dispatched at other times or with other quantities. With capacity leveling an optimal utilization of resources via detailed scheduling is achieved.

Process FlowCapacity planning can be carried out in two steps:

- Capacity evaluation to analyze capacity loads caused by planned orders (mid-term planning)

- Capacity leveling of planned and process orders (detailed scheduling)

Capacity Evaluation

Use

Capacity evaluations are used to analyse capacity loads in the production area e.g. in mid-term planning. Therefore different transactions are available. Available capacities and capacity requirements can be selected according to various criteria and cumulated using any period split you choose. Resources respectively resource capacities are grouped using different capacity planner groups like YP1 (SAPyrin production packaging) or YT1 (TuSAPin production).

PrerequisitesAvailable capacities must be maintained and capacity requirements e.g. planned orders from MRP run must be created.

Procedure1. Call up the transaction as follows:

Menu path Logistics Production - Process Process Planning Evaluation Resource View Load

Transaction code CM01

2. Enter the required data on the Capacity Planning: Selection.

Field name Description User action and values Comment

Work center

Cap. Planner Group

YP1 or YP2, YP3

Plant BP01

3. Choose Standard Overview.

4. Evaluate the capacity situation on the resources/work centers belonging to capacity planner group YP1. Due to MRP settings (lot size data) and planning data for the produced materials capacity requirements in different periods varies. Display and cumulating settings (e.g. periods) can be changed via Settings – General.

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5. To analyze a period in detail: Mark a period (e.g. with a capacity overload) and choose Cap. details/period.

6. In the Capacity Planning: Standard Overview: Details you see all planned and process orders scheduled for the chosen period. Each row represents a capacity requirement of an order. Choose Choose fields to change list of selected fields for display.

7. To change the basic or production data of e.g. a planned order mark the order and choose Order Header. Choose Planned Order to come to the Change Planned Order screen. Make necessary changes, choose Save and return to the Capacity Planning: Standard Overview: Details. Choose Refresh to evaluate the new capacity situation after your changes.

8. Choose Back several times to leave the transaction.

ResultAfter changing planned orders capacity overloads are reduced and a more stable capacity load per period exists.

Capacity Leveling

Use

Capacity requirements at the detailed planning level mainly arise from process orders, but also planned order might exist in the short time interval. During capacity leveling these orders are dispatched on production resources e.g. a bottleneck resource.

The graphical planning table (transaction cm29 ) enables you to carry out detailed planning of capacity requirements continuously over time. Thus the system dispatches the requirements at specific points in time and in the sequence in which they are to be processed.

In the planning table (tabular form; transaction cm35 ) available capacity and capacity requirements are shown in a period split. You can dispatch the capacity requirements to specific periods. You cannot dispatch capacity requirements to a period in a specific sequence.

PrerequisitesAvailable capacities must be maintained and capacity requirements e.g. planned orders from MRP run or process orders must be created.

Procedure1. Call up the transaction as follows:

Menu path Logistics Production - Process Process Planning Capacity Leveling Resource view Capacity planning table

Transaction code CM29

2. Enter the required data on the Capacity Leveling screen.

Field name Description User action and values Comment

Work center RES-1010 or any other resource for production

Plant BP01

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Capacity category

008

Cap. Planner Group

YP1 or YP2, YP3, YPT

3. Choose Execute (F8).

4. The graphical planning table starts with settings defined in standard profile SAPPI_G001 (in customizing other profiles can be maintained). This views contains two charts:

- The upper chart shows all the capacities for the resource.

- The lower chart shows all orders/operations that are in the pool for the resource.

(If you want to have detailed information on the used profile choose from menu Settings Display profiles)

To control main display settings for the planning table choose Settings. e.g. the axis scale might be set on an daily period split.

To control the planning or dispatching strategy profile choose Strategy (strategy profile SAP_T001) and check the settings for automatic dispatching. For the next step it might be helpful to turn off the finite scheduling and to activate date entry when dispatching functionality.

5. Basic steps to carry out during capacity leveling:

- Mark an order/operation to be dispatched

- Choose Dispatch (F5) and enter the Start Date

- Check the planning and/or scheduling log, if necessary. To have a closer look on the process order with the scheduled production times, double-click operation/order. Dispatched operation should have the operation status DSPT.

- After all operations/orders for your detailed planning period (e.g. one week) are dispatched check your production plan. Choose EDIT and FIXTIME PERIOD to protect this period from further changes.

ResultAll process orders in your short-term are dispatched. The production sequence for this resource is fixed.

As there exist several settings to work with the planning table which can be maintained via profiles in customizing or changed in dialogue refer to ERP documentation: Capacity Leveling (PP-CRP-LVL).

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Advanced Planning Board for mySAP ERP (P63)

This chapter is only valid if you use the functionalities of the Advanced Planning Board for mySAP ERP of OR Soft Jaenicke GmbH.

Be advised, that additional software is required for these functionalities.

PurposeThe advanced planning board supports the detailed production and execution scheduling (APS, MES) as well as the planning of the in-house supply chain. The planning situation and possible conflicts caused by the current schedule are visualized in a graphical display. Potential benefits of using the advanced planning board result from the easiness of getting an overview (transparency of the planned production process) and from the enhanced usability (scheduling and rescheduling of orders).

In comparison with the standard mySAP ERP planning table used for capacity leveling, the advanced planning board provides the following enhanced functions:

simultaneous scheduling of resource allocation capacity and material requirements simulations can be carried out large scale data can be efficiently handled by scheduling algorithm using an in-memory

database on the user PC the advanced planning board can be used as an advanced user interface for mySAP

ERP to integrate APS and MES functions

Advanced Business ModelThe advanced planning board introduces new types of dynamic data to

allow detailed scheduling simulations

bridge the gap between lightweight business objects (e.g. planned orders) that have no detailed scheduling data and heavyweight business objects (e.g. process orders) that have detailed scheduling data but may have some technical restrictions making them unsuitable for simulation and flexible, detailed rescheduling.

For full details, read the related documentation of Building Block Advanced Planning Board for mySAP ERP (P63).

Simulated Process Order:

A simulated process order is a detailed scheduling object for internal procurement that only exists for the APB but does not have an equivalent in mySAP ERP. It can be used in an intermediate stage of scheduling, e.g. when multiple partial quantities should be scheduled for a planned order.

Simulated Purchase Requisition:

A simulated purchase requisition is a detailed scheduling object for external procurement that only exists for the APB but does not have an equivalent in mySAP ERP. It can be used in an intermediate stage of scheduling, e.g. when advanced scheduling processes are used to resolve material shortages over multiple production stages and finally end in requirements for raw materials.

Scheduled Planned Order:

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A scheduled planned order is a mySAP ERP planned order loaded to the advanced planning board that has specific scheduling information and is thus treated differently by the APB.

There are two different flavors of these orders:

Scheduled Planned Order - ERP:

the mySAP ERP system has rough scheduling data as capacity requirements for the planned order.

Scheduled Planned Order - APS:

the plug-in YPORS1 has detailed scheduling data in separate tables that is interpreted by the APB. This may either be a procedure code to schedule the order automatically based on basic dates (this type is used in process APB1) or a more detailed scheduling information (this type is used e.g. in process APB3 and as a result of rescheduling with process APB2).

Process OverviewThe advanced planning board provides the following business process procedures:

APB1 Schedule planned orders at basic dates and convert into process orders

APB2 Reschedule scheduled planned orders and process orders

APB3 Schedule planned orders interactively and convert into process orders

APB4 Call of mySAP ERP Transactions

APB5 Execute ATP check for process orders

APB6 Plan predecessor products

APB7 Execute MRCP run –single level – from PIR

APB8 Execute MRCP run –multiple levels – from Materials Cockpit

APB9 Analyse and evaluate a production schedule

APB10 Unschedule scheduled planned orders

APB11 Publish, unschedule or remove simulated data

APB12 Remove scheduled planned orders

All business process procedures can be combined and used iteratively to achieve the desired planning result.

UseThe advanced planning board is used after the MRP run to schedule and reschedule planned orders and process orders.

PrerequisitesThe advanced planning board requires special software components provided by OR Soft Jaenicke GmbH. This software has been evaluated by SAP together with the SAP Best Practices for Pharmaceuticals package and documentation for its installation and use is contained in the SAP Best Practices for Pharmaceuticals package. However the software components are not delivered as part of the SAP Best Practices for Pharmaceuticals package.

Please contact [email protected] or use the order form at www.best-practice-solutions.com to obtain the CD SCHEDULE++ for SAP Best Practices for Pharmaceuticals free of charge.

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This CD contains:

Plug-in YPORS1 that needs to be installed on the mySAP ERP Server.

SAPGUI Extension SCHEDULE++ that needs to be started on the user PC.

The CD contains a preconfigured version for the Best Practices for Pharmaceuticals sample model (plant BP01) that can be run directly off the CD and does not require any installation or configuration.

The preconfigured version expects that you have used the predefined names for plant, material types, order profiles etc. when installing the sample model. In particular your plant name must be BP01. If you have used a different plant name, contact [email protected] to obtain a proper working version for your plant name.

The user PC must run with Microsoft Windows (NT, Win2000 or XP with current service level), at least a Pentium III processor and 256 MB RAM (this minimal requirement is valid for the preconfigured version for the sample model (plant BP01), productive scenarios often have higher requirements).

By default the plug-in YPORS1 is only activated for read operations to prevent any accidential change of mySAP ERP data. This allows the risk-free use of the advanced planning board as a analysis and overview tool for mySAP ERP even on a production system. In this case, you may only use the following business process procedures:

APB5 Execute Dynamic ATP check for process orders

APB9 Analyse and evaluate a production schedule

To use the full feature set and the described business process procedures, the plug-in must be activated for write operations. This action needs to be carried out only once for each mySAP ERP client that you want to access with the advanced planning board in write-enabled mode.

It is possible to use the advanced planning board in read-only mode on one mySAP ERP client (e.g. with production data) and in write-enabled mode on a different mySAP ERP client (e.g. with SAP Best Practice scenario data).

Additionally there must exist non-firmed planned orders for the example scenario (usually created by the MRP run).

Procedure1. Read the related documentation of Building Block Advanced Planning Board for mySAP

ERP (P63).

2. Use the business process procedures described in the documentation to achieve the desired planning result.

ResultYou have created a detailed production schedule represented in mySAP ERP by scheduled planned orders, process orders and purchase requisitions.

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Procurement of Stock Materials (P07)

PurposeThis building block is used to purchase raw materials and packaging materials for the production of SAPyrin tablets as Solid Dosage Form in plant BP01 ‘Production plant BP01.

The following storage locations are used:

0001 Standard warehouse for packaging materials,0004 Raw materials warehouseYP10 WM storage location

Material type

Material Material descriptionBatch

managedWM

managedVendor

ROH PH-1510 Acetic anhydrid X X S-1000

ROH PH-1520 Salicylic acid X X S-1000

ROH PH-1610 Cornstarch X - S-1003

ROH PH-1620 Cellulose powder X - S-1003

ROH PH-1630 Aspartam X - S-1003

ROH PH-1640 Polymer coating solution X - S-1006

YPPM PH-4100 Blister foil X - S-1004

YPPM PH-4200 Aluminum foil X - S-1004

YPPM PH-4501 Box SAPyrin X - S-1001

YPPM PH-4502 Box SAPyrin X - S-1001

YPPM PH-4503 Box SAPyrin X - S-1001

YPPM PH-4504 Box SAPyrin X - S-1001

YPPM PH-4910 Leaflet SAPyrin X - S-1001

ResultThe material requirements planning allows to plan all requirements for one plant (production and procurement) in advance.

Conversion of Purchase Requisitions (all materials)

UseThe purchasing department converts the purchase requisitions created by the user departments.

To reduce costs the procurement process should be done automatically without workload to high qualified purchasing employees. Especially with existing contracts and pricing conditions this can be done automatically.

Prerequisites

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The purchase requisitions were created. For each material the purchasing info records or contract items were created and entered in the source list. The source list is required for each material.

If Building Block Internal Stock Transfer without Delivery (P38) is to be used, consider the deactivation of the source list requirement !

For the automatic conversion the purchase requisition items need as source of supply a contract item to be assigned. In addition the following settings are required: In the master record for the vendor with whom the material is ordered, the field Automatic purchase order must be flagged in the control data for the purchasing data. The Autom. PO indicator must also have been set in the purchasing view of the material master record. Setting this flag has to be done manually for the following procedure.

Even if the fields Automatic purchase order are flagged in the control data for the master data the purchasing process can be processed manually. The procurement process is designed to use purchase requisitions and purchase orders. If you want to create purchase orders manually (transaction me21n) deselect Source list requirement flag in material master.

Procedure

Procedure described here is valid for all materials (batch/non-batch and WM/non-WM).

1. Creating purchase orders manually from purchase requisitions

1. Call up the transaction as follows:

Menu path Logistics Materials management Purchasing Purchase Requisition Follow-On Functions Assign and process

Transaction code ME57

2. Select the purchase requisition items to be converted in the Assign and Process Purchase requisitions screen:

Field name Description User action and values Comment

Material <Material number>

Plant BP01

Purchasing group 205 for Packaging material

3. Use the checkboxes to determine the scope of the purchasing requisitions to be listed and choose Execute.If you have assigned a fixed source of supply with the creation of the purchase requisition, select the Assigned purchase requisitions indicator to include the items in the list.

4. Assign the source of supply, select the purchase requisition items and choose Assign automatically (Shift+F6). The source of supply is displayed with each item.

This step is not required, if the purchase requisition already contains the source of supply.

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5. Convert the purchase requisition items to a purchase order.Choose Assignment overview (Shift+F5). Select a vendor in the list by placing the cursor in the line below where the purchasing organization is displayed. The convertion is started with the Process assignment (F2) pushbutton.

Field name Description User action and values Comment

Order type NB

Purchase order date < date >

Purchasing group 205 for Packaging material

Purchase organization BP01

6. In the transaction me21n ‘Create Purchase Order’ the requisition to be converted is displayed in the document overview on the left side of the screen. Select the requisition number(s) with the cursor and keep it pressed until the cursor is moved to the shopping basket symbol to be found in front of the field purchase order type (Drag and drop).

7. The purchase order header is created with the organizational data, see screen area Header:

Field name Description User action and values Comment

Purchase organization BP01

Purchasing group 205 for Packaging material

Company code BP01

8. The purchase requisition items are copied to the purchase order, see Item overview:

9. The net price is taken from the purchasing info record. The warnings can be suppressed with Enter. Choose Check (Ctrl+Shift+F3) and Save (F11). The successful creation is confirmed with the message Standard PO created under the number <No. of the purchase order>.

10. Choose Back (F3), the screen Assign and Process Requisitions: Overview of Assignments (transaction me57) is displayed again. The worklist was updated: The status ‘Ordered’ and the number of documents is displayed, see column ‘Processing note’.

11. The creation of additional purchase orders can be processed from that list. Leave the application by choosing Back (F3) twice and confirm the message Save assignments already made first with Yes. The message Purchase requisitions changed appears.

2. Creating purchase orders automatically from purchase requisitions

Prerequisites

In SAP Best Practices for Pharmaceuticals contracts are created during activation of Building Block Procurement of Stock Materials (P07) !

The following step takes into consideration that one material will delivered from one supplier (1:1 relationship) and has to be carried out once for automatic conversion of a purchase requisition to a purchase order.

1. Maintain the source list:

Menu path Logistics Materials management Purchasing Master Data Source List Maintain

Transaction code ME01

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2. Enter the material of the contract and the plant BP01 in the initial screen and choose Enter.

3. The following fields are required:

Field name Description User action and values Comment

Valid from Today or in future Comes from existing contract

Valid to Compare agreement validity

Comes from existing contract

Vendor < vendor > Comes from existing contract

Purchase organization BP01 Comes from existing contract

Agreement <No. of contract> Contract was created during activation of Building Block

Item <Item no.>

Fixed source of supply X

Source list usage in materials planning and control

1

4. Save your entries.

Alternatively using the transaction me05 source list entries can be generated automatically.

Since the MRP run does not have the data from existing contract it must be assigned to all purchase requisitions manually once.

5. Call up the transaction as follows:

Menu path Logistics Material Management Inventory Management Environment Stock Stock/Reqmts List

Transaction code MD04

6. Enter the required data on the Stock/Reqmts List/Initial Screen.

Field name Description User action and values Comment

Material PH-4501 or PH-4502,PH-4503,PH-4504

Plant BP01

7. Choose Enter.

8. Select an existing purchase requisition and double-click line.

9. On the upcoming Additional Data for MRP Element screen choose Change Element (F8)

10. On the Change Purch. Requisition XXXXXXXX screen enter the agreement number from existing contract in the Agreement field and the item number in the Item field.

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11. Assign the contract item as source of supply with the creation of the purchase requisition.

12. Now the automatic creation can be processed. Call up the transaction as follows:

Menu path Logistics Materials management Purchasing Purchase Requisition Follow-on functions Create Purchase Orders Automatically via Purchase Requisition

Transaction code ME59

13. Enter the required data in the selection screen Automatic creation of PO.

Field name Description User action and values Comment

Purchasing group 205

Purchase organization BP01

Plant BP01

14. Activate flag Per requisition in the New purchase order area.

15. Use the checkboxes in Other parameters to determine the scope of the detailed log to be listed and a test run to be done.

16. You can create the purchase orders by choosing Execute (F8). The PO numbers are shown in the log (not in test run).

This can also be done as a daily job.

Goods receipt (not batch managed, without WM)

This chapter is for information only. Since all materials in this scenario are batch managed the following chapter (Goods receipt (not batch managed, without WM)) is an example of a goods receipt with materials which is neither batch nor WM managed.

The goods receipt is posted with reference to a purchase order that have been created already.

1. Call up the transaction as follows:

Menu path Logistics Materials management Inventory management Goods movement Goods receipt For purchase order Purchase order number known

Transaction code MIGO

2. Enter the required data in the Goods Receipt for Purchase Order - <USER> screen.

Field name Description User action and values Comment

Executable action

field with no description A01 - Goods receipt

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Document number

field with no description R01 - Purchase order

Type of reference document

field with no description < purchase order number >

Movement type

field with dependent description

101 (GR for purchase order into warehouse/stores)

3. By choosing Enter, the items from the purchase order are listed and can be selected for transfer by selecting the OK field.

4. Choose Check.

If the message M7 053 Posting only possible in periods <year>/<month> and <year>/<month before> in company code BP01 appears, create a new session and close the period using the transaction mmpv (Logistics Materials Management Material Master Other Close Period): Enter from company code BP01 to company code BP01 and the next month as period and the fiscal year. Choose the indicator ‘Check and close period’ and Execute (F8). The successful log is displayed with the message Company code BP01 converted and Period closing complete. Go back to the transaction migo and choose Check again.

5. Choose Post if no messages or only warnings are displayed. The successful posting is confirmed with the message Material document <No. of material document> posted.

ResultThe stock was posted in the stock type Unrestricted use, see transaction mmbe ‘Stock overview’ (Logistics Materials Management Inventory Management Environment Stock Stock Overview). Select material and plant BP01.

Goods receipt (batch managed, without WM)In addition to the procedure described above select the detail data of the item and choose the Batch view to enter a batch number. Otherwise a new number is defined by the system and the program displays Creating batch <No. of batch> which has to be confirmed with Enter.

In both cases you have to enter here the date of production.

At goods receipt you have to enter a number of containers (in tab page Quantity), in order to generate the correct samples in QM (use unit CAN as container). Number of containers is available in the inspection lot after saving (transaction qa03, Insp lot quantities tab)

Choose Check and then Post. The successful posting is confirmed with the message Material document <No. of material document> is posted.

ResultThe stock is in stock type quality inspection (see transaction mmbe). Put the cursor on the batch and choose Extras Display batch. The batch was created with the batch status unrestricted use.

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An inspection lot has been created, (see also transation qa03, ‘Display Inspection lot‘ (Logistics Quality management Quality Inspection Inspection Lot Processing Display). The inspection lot created is suggested by the system.

Refer to the documentation for Building Block P18 (QM in Procurement) !

Goods receipt (batch managed, with WM)Refer to the previous chapter Goods receipt (batch managed, without WM).

Exception: Use the storage location YP10 ‘WM Storage Loc.’.

UseFor a goods receipt to purchase order the placement of stock into the Warehouse is needed.

PrerequisitesA Goods receipt to a purchase Order in the inventory management must be carried out.

Stock is on interim storage type 917.

The stock is released by a inspection lot from QM, refer to the chapter which describes QM in Procurement

Use chapter Quality Management in Goods Receipt without Sample Management for material PH-1510 and Quality Management in Goods Receipt with Sample Management for material PH-1520.

Procedure

Create Transfer Order

1. Call up the transaction as follows:

Menu path Logistics Logistics Execution Internal Whse Processes Transfer Requirement Display For Storage Type

Transaction code LB10

2. Enter the required data in the screen Display Transfer Requirement: List for Storage Type.

Field name Description User action and values Comment

Warehouse number

Warehouse number YP1

Source storage type

Source storage type 917 Quality assurance

Enter

All open Transfer Requests are displayed.

Select your Transport Request for your Purchasing Order

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TO in foregr. Click button Ctrl+Shift+F8

3. Enter the required data in the screen Create Transfer Order for TR xxx: Prepare for putaway.

Field name Description User action and values Comment

Puttaway foreground

Click button F5

4. Enter the required data in the screen Create Transfer Order from TR: Generate Transfer order Item.

Field name Description User action and values Comment

Destination Destination < destination type > e.g. 001

Section Section < destination section > e.g. 001

Enter Check entries

Enter

Post Menu: Transfer Order Post

Ctrl+S

ResultThe transfer order is created.

Confirm Transfer Order

1. Call up the transaction as follows:

Menu path Logistics Logistics Execution Inbound Process Goods Receipt for Inbound Delivery Putaway Confirm Transfer Order Single Document In One Step

Transaction code LT12

2. Enter the required data in the screen Confirm Transfer Order: Initial Screen.

Field name

Description User action and values Comment

TO number <Transfer order number>

Warehouse number

Warehouse number YP1

3. Choose Enter.

4. Enter the required data in the screen Confirm Transfer Order: Overview of TO Items.

Field name

Description User action and values Comment

Confirm internally

Click button F5

Post Ctrl.+S

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ResultThe system contains a confirmed transfer order. The goods are booked into the warehouse. Check the stock in transaction ls24.

Bin Stock per Material

UseOverview about the Material bin stock all over the different Storage types

PrerequisitesThe Materials is maintain for the Warehouse Management and stock is at the storage

Procedure1. Access the transaction using:

Menu Logistics Logistics Execution Internal Whse Processes Bins and Stocks Display Bin Stock per Material

Transaction code LS24

2. On the Stock Overview screen, enter the necessary data.

Field name Description User action and values Comment

Warehouse number

Warehouse number YP1

Material Material Number <Material Number>

Plant BP01

3. Choose Enter.

4. On the Stock per Material screen, double-click Storage Bin.

The Storage bin details are displayed in the screen Display Storage Bin.

5. On the Stock per storage bin area, select the Material line an choose Quant

The detail about the Quant is displayed)

ResultThe completely bin stock from one Material over all storage types is displayed.

Invoice Verification

UseAt the end of the logistical chain consisting of purchasing, inventory management and invoice verification, invoices are checked to ensure that they are correct in terms of general content, prices and arithmetic. When the invoice is posted, its data is saved in the system. The system updates the saved data for invoice documents in Materials Management and Accounting.

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PrerequisitesThe master data for material, account determination and vendor must have been maintained, e.g. material PH-1810, vendor S-1000.

The purchase order must have been created, e.g. 45xxxxxxxx.

The goods receipt must have been posted, e.g. 50xxxxxxxxx.

Procedure1. Access the transaction choosing one of the following navigation options:

SAP Menu Logistics Materials Management Logistics Invoice Verification Document Entry Enter Invoice

Transaction code MIRO

2. If you are opening for the first time this transaction, the system will ask for Company Code. Enter the company code in the dialog box Company Code:

Field name Description User actionand values

Comment

Company Code BP01

3. Choose Continue (Enter).

The Enter Company Code screen may not appear, if you have already executed this transaction. On the Enter Incoming Invoice: Company Code <Company Code> screen you can change the company code choosing Edit Switch company code (F7).

4. Enter the required data in the screen Enter Incoming Invoice: Company Code BP01:

Field name Description User actionand values

Comment

Transaction Invoice Default by system If requested, select other transactions from drop down list

Header Data Header data of Invoice

Defaulted by system after entering purchase order

e.g. vendor master data

Basic tab Basic information tab

Select basic information tab page to give initial information

Invoice Date Invoice Date Enter the Vendor invoice date

Reference Invoice reference

Enter the vendor invoice reference

Field is mandatory

Posting date Posting Date Enter the posting date of document

System will give current date as default

Amount Invoice Amount

Enter invoice gross amount including taxes and duties

Consider VAT and get the price from purchase order

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Field name Description User actionand values

Comment

Currency Enter the currency in which the invoice is presented by vendor, if not entered by user system will default the document currency from purchase order

User Input

Calculate tax Check box calculate tax

Set the flag for the tax calculation

The field tax amount is automatically filled

Tax drop down list Tax code Enter input tax If required, select input tax from drop down list

Text Text Enter text if required for reference

Payment tab Payment tab Select payment details tab page

Baseline Dt Base line date for payment

Enter the base line date for payment

Will be defaulted if payment terms entered in purchase order

Pmnt terms Payment terms

Payment terms of document, if entered will be defaulted from purchase order

Due on Payment due on

Will be calculated by system

Grayed out

Discount Cash discount Enter if cash discount is offered by vendor

Purchase order / Schedule Agreement

Select Purchase order / Schedule Agreement in the reference document category from drop down list

Defaulted for user

Purchase order number

Enter the purchase order number, e.g. 45000000##

Goods / service items

Select Goods / Service items in indicator from drop down list

Defaulted

Layout Layout of invoice verification

Select All information from drop down list

5. Choose Enter to complete the document feeding part.

6. To check the document credit and debit is balanced on the top right corner of your screen, a traffic light is displayed. Beside that Balance of the document is displayed.

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Ensure that the Balance is ZERO before posting the document and the traffic light is green or yellow color.

7. If you want to see the accounting postings in simulation mode, choose Simulation on ´middle of fourth row of your screen

During this process you may get a warning message displaying as Part II is not posted, ignore and choose Enter to continue. As this is not required – Subcontracting process

8. Choose Save for posting the document.

Result

Logistics Invoice verification document is posted and simultaneously the system creates an accounting document.

If any discrepancies occur and these lie within the tolerances created in the Customizing area (yellow traffic light), then the invoice can be posted but it is blocked for payment and must be released before it can be paid.

If any discrepancies occur which lie outside these tolerances, the invoice cannot be posted.

Automatic Payment Transactions / Payment Program

PurposeThe payment program enables you to carry out automatic domestic and international payment transactions with vendors and customers. It creates the payment documents and makes the data available for the payment medium programs. These ABAP programs either print a payment list or payment form (checks, for example), or create data media/files, which can then be sent to the bank on disk or with special bank software.

The payment medium program stores data in the SAP print management system and DME administration system (for DME). Here, the data is retrieved separately for each form/data medium and can be transferred in the required manner.

After a successful payment run, the open customer or vendor items are paid, the items cleared, and payment media created, which you can send to the bank.

In the open item, you can specify a payment currency different than the document currency. You can also specify an amount that is then paid instead of the gross amount of the item. This means that it represents the gross amount of the item in the payment currency.

Vendor items can be paid using the following methods:

Payment Method Description

L Foreign bank transfer

O Order check

P Postgiro (Post office bank)

R EU internal transfer

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S Check

U Bank transfer

Customer items can be paid using the following methods:

Payment Method Description

A Bank direct debit

E Bank collection

All currencies are permitted for payment methods L, O and S. The other methods can only be used with euro (EUR).

Prerequisites

Customizing

You have made all settings for payment method and/or bank selection that control the payment program

Master Data

The methods used to pay the open items must be defined in the relevant vendor/customer master data. The following data is used in this document:

Business Partner Payment Method

Vendor S-1000 SU

Before each payment run, specify which payment methods can be used in the payment run. If a payment method that is permitted for the payment run is explicitly specified in the open item or in the business partner master record, the payment program chooses this method. The payment method in the open item, therefore, has priority over a payment method in the master record.

If several payment methods are specified in the master record and none is specified in the item, the payment program chooses an appropriate method. The program checks the payment methods you specified for the payment run to determine whether they are permissible (they are checked in the same order you specified them).

For more information on creating customers and vendors, see the relevant documentation.

If you are using the dual control principle and have changed sensitive fields (bank details in customer/vendor master data, for example), you must ensure that your changes are released before starting the payment program, otherwise the items for this business partner cannot be paid using the payment program.

Terms of Payment

The terms of payment used and the baseline date for payment determine when the open items are due. The document date has been set as the baseline date for all the terms of payment.

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Payment Block Reasons

You must block items that are not to be paid, irrespective of their due date. To do so, enter a block key in the item to represent the block reason. If a business partner account is to be blocked for payment, enter the block key in the master record of the business partner.

The following payment block reasons have been defined in the system (you can change them or add more):

Block Ind. DescriptionCan be changed in payment proposal

Manual payment block

Cannot be changed

Free for payment

* Skip account

A Blocked for payment X X

B Blocked for payment

N Postprocess inc.pmnt X

P Payment request X X

R Invoice verification X X

S Other reasons X X

V Payment clearing X

The payment program creates a payment proposal during the payment run. The payment is made on the basis of the payment proposal. The blocked items are listed separately. You can process the payment proposal and, for example, set/reset the payment block for an item.

A block key can be set in such a way that it cannot be changed in the proposal.

Block reason ‘*’ has to be entered in the master record for vendors in case of their open items have been debited from the accounts automatically or via a bank direct debit transaction. To ensure that these items are not paid again by the payment program, the program skips all items with block key ‘*’.

Block key ‘P’ is used by Treasury.

Block keys ‘*’, ‘A’, and ‘P’ are supplied by SAP and must not be changed.

Cash Discount

The maximum cash discount always applies (if it complies with the terms of payment). This rule applies to vendors and customers alike. Using the next payment run date, the payment program determines whether a payment with deduction of cash discount could still be made in the next payment run. If so, the open item is not paid until the next payment run. If payment is not possible on the next payment run date, however, the item is paid immediately (if possible, taking cash discount into account).

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Selecting Banks and Planning Available Amounts

During the payment run, therefore, the payment program attempts to determine a house bank and a bank account for which the available amount is sufficient for the payment. The following results are possible:

No house bank is found that fulfills all the conditions, which means that the payment cannot be made with the method used to carry out the check. The system then checks the next available bank. If no bank is found, the payment method cannot be used. The next payment method (if one exists) is checked. This is recorded in the payment run log.

One house bank only is determined. The payment is made by this house bank.

The system lists several house banks. The payment is made by the house bank with the highest priority (in accordance with the defined ranking order of the banks).

If you want to specify in the item which bank is to make the payment, you can enter the appropriate bank ID.

The system is set in such a way that outgoing payments are generally only made via the house banks DB (Deutsche Bank) and PB (Postbank). Incoming payments can be posted at all the house banks because the cash concentration function can be activated in Cash Management; in other words, all the other accounts are cleared and transferred to the Deutsche Bank accounts in the evening.

Before starting the payment program, you have to define the available amounts for all the banks. To do so, choose the following menu path: Accounting Financial Accounting Accounts Receivable Environment Current Settings Available Amounts for the Payment Program.

For the selected banks, the payment program checks whether the available amounts in the bank accounts are sufficient. For your house bank accounts, you can specify available amounts for incoming and outgoing payments separately (see the following table). For outgoing payments, you define which amounts are available. For incoming payments, you define the maximum amount to be paid into a bank account. If the defined limit is exceeded, the payment program must choose different bank details. You control the bank account used to make payments on the basis of the available amounts. You should update the amounts before each payment run.

The payment run does not split the amounts. If the amount in a bank account is not sufficient for a payment, the payment program chooses a different bank account. If no other bank account is found from which it can post the total amount of a payment, the payment is not made. The value days enable you to plan amounts on a graduated time scale. You generally only have to do this when you post payments by bill of exchange before the due date. In all other cases, you can enter 999. The specified value dates are maximum values.

Incoming payments can be made to all banks. Outgoing payments can only be made by the house banks DB and PB. To avoid payments being made inadvertently by the house banks BW and DRE, the available amounts for the outgoing payment must be left set to ZERO.

Posting Open Items

To execute the payment program, you first have to post a number of open vendor and customer items.

The vendors and customers are created using master data eCATTs. For more information, refer to the Accounts Payable Accounting: Master Data and Accounts Receivable Accounting: Master Data business process procedures.

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Executing the Payment Program

Entering Parameters

1. Call up the transaction as follows (Vendors):

Menu Path Accounting Financial Accounting Accounts Receivable Periodic Processing Payments

Transaction Code F110

2. Call up the transaction as follows (Customers):

Menu Path Accounting Financial Accounting Accounts Payable Periodic Processing Payments

Transaction Code F110

3. On the Automatic Payment Transactions: Status screen, enter the required data.

Field Name Description User Action and Values Comment

Run Date The run date is used to identify the parameters and is the date on which the program is to be run. The program can also be run, however, at an earlier or later date.

Enter today’s date

Identification Additional identification feature, which can be used to differentiate between several runs with the same reconciliation key date. The ID is user defined.

Enter a unique alphanumeric ID (your initials and a sequence number, for example)

e.g. NN001

Status Tab Page

The status of the payment run is displayed on the Status tab page, thereby enabling you to monitor which steps the payment program has carried out.

Parameter Tab Page

3. Choose Parameter.

4. On the Automatic Payment Transactions: Parameters screen, enter the required data.

Field Name Description User Action and Values Comment

Posting Date Date under which the payment document is entered in accounting/cost accounting

Enter the day on which your payment document is to be posted. Enter today’s date.

Docs Entered Up To

Date up until which open items are to be included in processing.

The day of entry rather than the posting date is important here.

Enter today’s date.

Customer Items Due By

Date by which an open customer item must be due for it to be included in the payment

Enter today’s date plus 7 days. All customers’ items that are due by next week

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run. If you do not make an entry here, the date on which the payment run was posted applies. If you also want to pay items that are not due until after the posting date, you have to enter a later date.

are now paid.

If you enter a date that deviates from the posting date by more than 14 days, the system displays a warning.

Company Codes

In this field, you enter the company codes for which the payment run is to be started.

Enter the company code BP01

Payment Methods

List of payment methods that are to be used in the payment run. You enter the required payment methods (with no additional separators). The order of the keys determines which payment methods are to be used to pay the open items, without the need to specify a particular payment method in the open item or master record.

Enter the string UPSORLAE. This means that the payment program will first attempt to use payment method U. If this is not possible, payment method P will be checked, and so on.

The print programs depend on the payment methods selected.

Next Posting Date

Enter the date on which the next payment run is posted. The program uses this date to determine whether the open items are paid in this payment run or in the next payment run.

Enter today’s date plus +30 days.

Accounts Enter the account numbers of the vendors/customers that are to be included in this payment run.

Vendors: S-1000 – S-9000

Customers: C-1000 – C-9000

Additional Log Tab Page

5. Choose Additional Log.

6. In the Automatic Payment Transactions: Additional Log screen, enter the required data.

Field Name Description User Action and Values Comment

Due Date Check

Trace for determining the due date. This defines that the due date check for the open items is logged.

Activate

Payment Method Selection in All Cases

Trace for selecting the payment method. This ensures that the payment method and banks selected are logged.

Activate

Line Items of the Payment Documents

Trace for payment documents. This ensures that all the posted documents are printed in the log with their line items. With payment proposals, the documents that were created in the subsequent payment are

Activate

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printed.

Vendors (From/To)

In these fields, you enter the vendor numbers for which additional logs are to be created.

Vendors: S-1000 – S-9000

Customers (From/To)

In these fields, you enter the customer numbers for which additional logs are to be created.

Customers: C-1000 – C-9000

Printout/Data Medium Tab Page

7. Choose Printout/Date Medium.

8. In the Automatic Payment Transactions: Printout and DME screen, enter the required data.

Field Name Description User Action and Values Comment

Program This field displays the programs used to create payment media when the payment program is executed.

You do not have to enter any data here

Variant The variants contain a range of selection criteria according to which the payment data is separated. For every variant of a payment medium program called up, separate print requests are created in the print management system / files in the DME administration system. Each print request is displayed in the print management system. You can call up the print requests individually to print them.

Example: you execute the payment run for the payment methods ‘Check’ and ‘Order check’ using the RFFOD__S program. The payment program creates print data for this payment run. Since each payment method uses specific forms, you define a separate selection variant for each payment method for the RFFOD__S print program. A print request for each variant is entered in the print management system.

Enter the following variants for the print programs:

Print program RFFOD__L:

Variant1: BPFIDE_L

Print program RFFOD__S:

Variant1: BPFIDE_S_10

Variant2: BPFIDE_S_20

Print program RFFOD__U:

Variant1: BPFIDE_U

The following print programs are displayed depending on the payment methods selected (parameters):

RFFOD__L for payment method L;R

RFFOD__S for payment method O;S

RFFOD__U for payment method A,E,P,U

9. Choose Save Parameters. The system displays a message informing you that the details for your run have been saved.

10. Choose Back (F3). The Status tab page is displayed again. The current status is: Parameters have been entered.

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Because a printer has not been entered in the program variants, the printer from the user master record is used. Choose System User Profile Own Data to make sure that an output device has been entered on the Defaults tab page.

Scheduling Proposals

1. Choose Proposal or the following menu path: Edit Proposal Schedule Proposal. The Schedule Proposal dialog box is displayed.

2. Choose Start Immediately and then Schedule (Enter).

3. Keep choosing Status until the status text changes to Payment proposal has been created.

4. Then choose Edit Proposal Display Log to call up the proposal log. You can use the log to see whether items have been paid, or why they may not have been paid. Note that you cannot navigate in the log when the CATT is running.

5. Call up the payment proposal list by choosing Edit Proposal Proposal List. The system displays the List Variant dialog box. Choose Continue (Enter). The proposal list is then displayed. Note that you cannot navigate in the payment proposal list when the CATT is running.

6. Choose Back (F3) to return to the payment program.

Editing Proposals

1. Choose Edit Proposal (Shift+F4) or the following menu path: Edit Proposal Schedule Proposal. The Schedule Proposal dialog box is displayed.

2. In the Accounting Clerk dialog box, choose All Accounting Clerks.

3. In the Edit Payment Proposal: Payments screen, edit the payment proposal. In this screen, you can

Change the payment method

Change the house bank

Change the due date for a payment

Block/unblock line items

Change the cash discount amount

Assign line items to a different payment

For more information, refer to the documentation for the payment program.

4. Choose Back (F3) to return to the payment program.

You cannot edit the payment proposal in the CATT.

Scheduling Payment Runs

Once you have changed all the required items, you can schedule the payment run.

5. Choose Payment Run or Edit Payments Schedule Payments. The Schedule Payment dialog box is displayed.

6. Choose Start Immediately and Create Payment Medium. Then choose Schedule (Enter).

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7. Keep choosing Status until the status text changes to Payment run has been carried out. The status text then changes to Posting orders: X generated, X completed.

8. Next choose Edit Payments Display Log to call up the payment log. The log contains information on the items paid, payment document numbers, spool numbers for the payment media, payment summaries, and payment advice notes as well as the DME file numbers for data medium exchange. Note that you cannot navigate in the log when the CATT is running.

9. Call up the payment list by choosing Edit Payment Payment List. The system displays the List Variant dialog box. Choose Continue (Enter). The payment list is then displayed. Note that you cannot navigate in the payment list when the CATT is running.

10. Choose Back (F3) to return to the payment program.

You can schedule the payment run without a proposal run. The Schedule Payment dialog box then appears when you schedule the payment run. Here you can decide whether the payment run is to be scheduled in spite of the fact that no proposal has been created.

Printing the Payment Media

The file for data medium exchange is created immediately. You can display the DME files created with the payment run by choosing Environment Payment Medium DME Administration (transaction fdta). To download the payment media, select the required entries and choose Edit Download (this activity can be created only if payment media have been created). In the File Name dialog box, enter the target directory and the file name. Then choose Download (Enter).

The print program variants are configured in such a way that you have to trigger the payment media output via output control (System Own Spool Requests). This enables you to place the appropriate check forms in the printer before printing the checks, for example.

In the output controller, you can print out the payment media, payment summaries and payment advice notes that have been created. To do so, select the relevant spool request and choose Print Directly.

The CATT does not support functions for downloading the DME files or printing out the payment media.

ResultThe payment run has been executed. The open vendor and customer items have been cleared. The payment media, DME files and associated lists have been created.

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QM in Procurement (P18)

PurposeIn the pharmaceutical industry, all raw materials and primary packing is subject to strict checks. Some of these checks are carried out by the vendor, and some by the manufacturer. In SAP Best Practices for Pharmaceuticals, ALL raw materials and primary packaging are subject to obligatory quality inspection, which is modeled in the ERP QM module. When a goods receipt is posted, the ERP System creates an inspection lot, which must be processed.

All raw materials and primary packaging are generally subject to QM, and are checked using an inspection plan (1 characteristic IDENTITY ok, not ok). Special QM functionalities are mapped for certain materials.

The following raw materials/packaging in Plant BP01 are affected by QM in the scenario Solid dosage forms (P50):

PH-1510 Acetic anhydrid

PH-1520 Salicylic acid: The inspection, including sample management (physical samples) is carried out

PH-1610 Cornstarch: A QM-info record to vendor S-1003 exists

PH-1620 Cellulose

PH-1630 Aspartam: QM inspection as described herein only when material is procured from vendor S-1003

PH-1640 Polymer coating solution

PH-4100 Blister

PH-4200 Aluminum foil

PH-4910 Leaflet

PH-4501 (and PH-4502, PH-4503, PH-4504 respectively) Box SAPyrin

Quality Inspection in Goods Receipt (without Sample Management)

1. Results RecordingIn this QM scenario, a QM inspection is carried out for the goods receipt for a purchase order. The characteristics to be inspected, together with specifications, are allocated automatically from an inspection plan. The inspection lot is also created automatically. The materials affected are PH-1510, PH-1620, PH-1630 (QM inspection as described herein only when material is procured from vendor S-1003), PH-1640, PH-4100, PH-4200, PH-4910 and PH-4501 (and PH-4502, PH-4503, PH-4504 respectively)

The processes described below can be worked through for all these materials.

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PrerequisitesThe QM view in the material master must be maintained for all materials; inspection type 01 must be active; a valid inspection plan must be allocated to the material. A goods receipt for purchase order has to have been carried out.

ProcedureYou should also consult the standard ERP documentation on this point.

1. Call up the Worklist: Results Recording transaction as follows:

Menu path Logistics Quality management Quality inspection Worklist Results recording

Transaction code QE51N

2. On the right-hand side of the Worklist: Results Recording screen, enter the required data.

Field name Description User action and values Comment

Plant Plant BP01

Lot origin 01 (Inspection lot from goods receipt for purchase order)

Material Material number PH-1620 or in the same way for all other raw materials above

Batch Batch number If known from goods receipt

Vendor Vendor number

3. Choose Execute (F8), and the selected inspection lots are displayed on the left of the screen.

4. Record your inspection result in the template on the right (Identity = OK), valuate it, and close it.

5. Save the recorded results.

ResultThe inspection lot with the characteristic identity has been processed. The results for the inspection lot have been saved. The usage decision can now be made.

2. Recording the Usage DecisionWhen results recording is complete, the usage decision for the material can be made. Normally, this corresponds to releasing the raw material for production.

When the usage decision acceptance is saved, the material is automatically posted to unrestricted stock in ERP. In all other cases (with transfer postings, rejections, or similar), items have to be posted manually from within the usage decision.

PrerequisitesThe inspection results for the inspection lot has been recorded, valuated, closed, and saved.

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ProcedureYou have the option of branching directly from results recording (see previous point) to usage decision. You can do this after you have saved the results by double-clicking the top line of the inspection lot (on the left-hand side of the screen).

1. Alternatively, call up the transaction as follows:

Menu path Logistics Quality management Quality inspection Inspection lot Usage decision Record

Transaction code QA11

2. In the Record usage decision screen, enter the required data.

Field name Description User action and values Comment

Inspection Lot Number of inspection lot

Enter inspection lot number of search with F4

3. In the next screen, the usage decision code is entered.

Field name Description User action and values Comment

Selected set 01 Goods receipt

UD Code UD Code description A Enter A for acceptance

Batch Status Batch Status Set to unrestricted stock Change from restricted to unrestricted

4. A confirmation appears automatically when the usage decision is saved.

ResultIn the case of acceptance, the material is automatically posted to the unrestricted stock.

The usage decision code is written to batch classification automatically. You can see this in the transaction msc3n (display batch, enter material, plant, and batch number).

In the case of a rejection, the material must be posted manually.

If some of the inspection results have not been entered, valuated, or closed, the system informs you that inspection characteristics are still open. If this is the case, you must go back to the results recording function and carry out these actions, or force inspection completion (by confirming the appropriate message).

Quality Inspection in Goods Receipt (with Sample Management)

1. Results RecordingRaw materials are usually delivered in several containers, from which samples must be drawn. Pooled samples are created and a reserve sample is usually drawn and stored for a longer period. The samples can be created automatically in ERP QM when a goods receipt is posted to the material.

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In the preconfigured system for the pharmaceutical industry, this scenario can be worked through using the example PH-1520. Five samples are drawn, from which two pooled samples are created. A reserve sample is also drawn. The samples are allocated to a batch, the results recorded, and a release made.

Prerequisites

The material salicylic acid (PH-1520) in Plant BP01 is subject to QM.A sample-drawing procedure is created (SP-01), which specifies that 5 physical samples have to be drawn, as well as two pooled samples from these.

In this case, the system is configured so that the samples drawn have to be confirmed separately in order to record results for the sample. The confirmation indicator is set in the sample-drawing procedure.

Additionally the indicator for Check number of containers is set, i.e. the number of samples is dependent from the number of containers. You must enter the containers during goods receipt (transaction migo).

In the material master, inspection type 01 is active.

The inspection is carried out with an inspection plan. The sample-drawing procedure is entered in the inspection plan.

Sampling procedures (SP-12, SP-13) for inspection points/sample management must be allocated to the characteristics in the inspection plan.

Goods receipt for purchase order for salicylic acid must be posted.

In this case, the system is configured so that the samples drawn have to be confirmed separately in order to record results for the sample.

ProcedureInspection lot and samples are created automatically when the data is saved. The material is posted to Q-stock.

Alternatively, an inspection lot can also be created manually. Specification allocation via the inspection plan is carried out automatically (only if a valid plan exists).

1. First, you have to release the physical-sample drawing. Call up the transaction as follows:

Menu path Logistics Quality management Quality inspection Sample management Physical-sample drawing Edit

Transaction code QPR4

2. In the selection screen, use F4 to search for the correct physical-sample-drawing number (search help via material or inspection lot or batch).

Field name Description User action and values Comment

Plant Plant number BP01

Material Material number PH-1520

3. Select the physical-sample-drawing number; select all the entries and choose Release in the menu bar.

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4. For recording results call up the transaction as follows:

Menu path Logistics Quality management Quality inspection Worklist Results recording

Transaction code QE51N

5. Enter the required data in the Results Recording screen.

Field name Description User action and values Comment

Plant Plant BP01

Lot origin 01 (Inspection lot from goods receipt for purchase order)

Material Material number PH-1520

Batch Batch number If known from goods receipt

Vendor Vendor number

6. After the appropriate inspection lot has been selected, the results have to be recorded for the individual pooled samples.

Each sample is valuated individually (like an inspection point) and closed. You should also consult the standard ERP documentation on this point.

ResultIn each case, two pooled samples must be proposed with two operations: identity and lab analysis. Beneath each of these are two characteristics, appearance and identity, as well as purity and melting point.

After the results have been recorded and closed, the usage decision can be made.

You also can perform a sample storage, i.e. for the reserve sample (QM Q-inspection sample management physical sample)(transaction qpr2)

2. Recording the Usage DecisionRefer to Recording the Usage Decision in the previous chapter and proceed as described there.

ResultIn the case of acceptance, the material is automatically posted to the unrestricted stock.

The usage decision code is written to batch classification automatically. You can see this in the transaction msc3n (display batch, enter material, plant, and batch number).

In the case of a rejection, the material must be posted manually.

If some of the inspection results have not been entered, valuated, or closed, the system informs you that inspection characteristics are still open. If this is the case, you must go

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back to the results recording function and carry out these actions, or force inspection completion (by confirming the appropriate message).

Quality Inspection in Goods Receipt with Inspection Plan and Quality Info Record

1. Results RecordingIn this QM scenario, a QM inspection for goods receipt is carried out with an inspection plan; the inspection lot is created automatically at goods receipt. Initially, the purchase order can be only carried out with a specific vendor. By means of the quality info record in conjunction with material master settings, QM can also be used to specify that particular raw materials may be purchased only from particular vendors. It’s possible to enter a release quantity and a date, on which the material for the plant can be ordered from the vendor. In addition to this, a status profile is stored, which is used to specify that the first goods receipt from this vendor is treated as a specimen delivery. The complete quantity is treated as a specimen quantity in the inspection lot. The example here is the material PH-1610 (Cornstarch).

PrerequisitesThe QM view in the material master must be maintained for the material; inspection types 01 and 0101 must be active; and the QM indicator must be set in procurement.

A valid inspection plan with task list usage 5 and 51 must be allocated to the material.

A goods receipt for purchase order of the material PH-1610 must exist. The vendor in this case is S-1003.

ProcedureYou should also consult the standard ERP documentation on this point.

1. Call up the Worklist: Results Recording transaction as follows:

Menu path Logistics Quality management Quality inspection Worklist Results recording

Transaction code QE51N

2. On the right-hand side of the Worklist: Results Recording screen, enter the required data.

Field name Description User action and values Comment

Plant Plant BP01

Lot origin 01 (Inspection lot from goods receipt for purchase order)

Material Material number PH-1610

Batch Batch number If known from goods receipt

Vendor Vendor number S-1003

3. Choose Execute (F8), and the selected inspection lots are displayed on the left of the screen.

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4. Record your inspection result in the template on the right (Identity = OK), valuate it, and close it.

5. Save the recorded results.

ResultThe inspection lot with the characteristic identity has been processed. The results for the inspection lot have been saved. The usage decision can now be made.

2. Recording the Usage DecisionRefer to Recording the Usage Decision in the previous chapter and proceed as described there.

ResultIn the case of acceptance, the material is automatically posted to the unrestricted stock.

The usage decision code is written to batch classification automatically. You can see this in the transaction msc3n (display batch, enter material, plant, and batch number).

In the case of a rejection, the material must be posted manually (via stock for inspection lot).

With this vendor's first 2 deliveries you receive the suggestion that the entire inspection lot quantity be used as a specimen quantity for the stock posting.

On the tab page stocks for inspection lot, you can then specify whether the material should be posted as a specimen or normally into the unrestricted stock (enter appropriate quantities).

If some of the inspection results have not been entered, valuated, or closed, the system informs you that inspection characteristics are still open. If this is the case, you must go back to the results recording function and carry out these actions, or force inspection completion (by confirming the appropriate message).

Recurring inspection with copy of inspection results

UsageMaterials which are stored for a longer time period have to be checked regularly according to their chemical-physical properties which might change during this time. For this purpose the function recurring inspections can be used. As prerequisites inspection type 09 has to be activated in the respective material master, an inspection plan with usage 9 has to be maintained for these materials and the field inspection interval has to be maintained in the QM view of the material master. The inspection interval defines the period in which inspections are carried out regularly. Based upon this value the field next inspection in the batch master will be filled.

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In addition, the function copy of inspection results is deployed in the process. By using it, results of previously created inspection lots for the same material and batch are copied to a new inspection lot. This enables the user to compare directly during result recording current and past inspection results. He can then accept the values or change them.

PrerequisitesA recurring inspection for the material PH-1510 (Acetic anhydrid) has already been carried out. The batch has still some stock and the field Next inspection in the batch master shows a date in near future (max. 99 days following the current date).

ProcedureIn a productive system the recurring inspection will normally not be started manually but by a job which is started regularly in the back ground. For demonstration purposes the manual process is described here.

1. Call up the following transaction:

Menu path Logistics Quality Management Quality Inspection Worklist Inspection Lot Creation Deadline Monitoring Trigger Manually

Transaction code QA07

2. Enter the following data in the Deadline Monitoring of Batches Screen:

Field Description User action and values Comment

Material PH-1510

Plant BP01

Initial run in days 31 All batches with stock will displayed whose Next inspection have to take place within the next 31 days

To insp.stock at lot creation

X Mark this option so that the stock of relevant batches will be posted to Q stock

Block batches „ „ Demark this field.

3. Start the selection with F8.

4. Afterwards a protocol will be displayed. When you expand the structure in the upper part of the screen inspection lot and material document numbers will be displayed if batches were found which meets the specifications. By double-clicking an entry detailed data (material, plant, batch, storage location) will be shown in the second part of the screen.

5. Perform result recording and usage decision as described in the previous chapters of this document. If a previous inspection lot (inspection type 09) for the same material and batch exists the results will be copied from this lot to the new one. Now you can directly compare current and past results and you can accept the proposed values it they are still valid. The protocol of the result copy can be called during display of the inspection lot (transaction qa03) using the menu path Extras Transfer Log.

6. Check the field Next inspection in the batch master. It should correspond to the current date plus the inspection interval defined in the material master (QM view).

Menu path Logistics Central Functions Batch Management Batch

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Display

Transaction code MSC3N

7. Enter the following data on the screen Display Batch:

Field Description User action and values Comment

Material PH-1510

Batch Batch of the previously created inspection lot

Plant BP01

8. Check the field Next inspection. If the above mentioned inspection lot was the first with inspection type 09 for this material and batch no result copy took place during creation of the inspection lot. To create a second inspection lot for the same batch change this field in transaction msc2n (Change Batch) and enter a date in near future (not more than 99 days in future). When you repeat now steps 1 to 5 the previously entered inspection results should be copied in this new inspection lot.

ResultBatches can be inspected repeatedly in predefined periods using this function. Inspection results of previous inspection lots for the same material and batch will be copied into the new lot. This enables the user to compare directly current and previous results.

WM Integration (P06)

PurposeWith the assignment of plant/storage locations in Inventory Management (IM) to the warehouse number in the Warehouse Management System (WM), the total stock balance between IM and WM remains the same when you post goods receipts and goods issues that result in stock quantity changes in the system. For these goods movements, two postings are normally required to complete the process – one in IM and one in WM. It is possible, however, to almost completely automate this process.

Goods receipts are inbound movements of stock that has been received as the result of a purchase order, production order and for other reasons. All goods receipts result in an increase in the total stock in IM and WM. The IM posting increases the total stock in IM and WM at the same time. In this case, WM has a distribution function to move the stock that was posted in IM from the goods receipt area to storage bins in the warehouse. For this purpose, a transfer order is created to determine the most appropriate storage bins. After the stock has been moved, the transfer order is confirmed.

Transport order for Goods Receipt to Purchase OrderFor a goods receipt to purchase order the placement of stock into the Warehouse is needed.

PrerequisitesA goods receipt to a purchase order in the inventory management must carried out. Stock is on interim storage type 917 and it is released by an inspection lot from Quality Management.

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1. Create Transfer Order1. Access the transaction choosing one of the following navigation options:

Menu path Logistics Logistics Execution Internal Whse Processes TransRquiremt Display For Storage Type

Transaction code LB10

2. Enter the required data on the screen Display Transfer Requirement: List for Storage Type.

Field name Description User action and values Comment

Warehouse number

Warehouse number

YP1

Source storage type

Source storage type

917 Quality assurance

3. Choose Enter and all open Transfer request will be displayed.

4. Select your Transport Request for your Purchasing Order and choose TO in foregr. (Menu: Edit\ Put Away\Foreground: Ctrl+Shift+F8) .

5. Enter the required data in the screen Create Transfer Order for TR xxx: Prepare for putaway.

6. Choose Putaway foreground (F5).

7. Enter the required data on the screen Create Transfer Order from TR: Generate Transfer order Item.

Field name Description User action and values Comment

Destination Destination <Destination Type>

Section Section <Destination Section>

8. Choose Enter, check entries and choose Enter again.

9. Choose Post (Ctrl + S) (Menu: Transfer Order\Posting)

ResultThe Transfer Order is created.

2. Confirm Transfer Order1. Access the transaction choosing one of the following navigation options:

Menu path Logistics Logistics Execution Inbound Process Goods Receipt for Inbound Delivery Putaway Confirm Transfer Order Single Document In One Step

Transaction code LT12

2. Enter the required data on the screen Confirm Transfer Order: Initial Screen.

Field name Description User action and values Comment

TO number <Transfer order number>

Warehouse number

Warehouse number

YP1

3. Choose Enter.

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4. On the screen Confirm Transfer Order: Overview of TO Items choose Confirm internally (F5).

5. Choose Post (Ctrl + S).

ResultA confirmed transfer order exists. The goods are posted into the warehouse. You can check the stock with the transaction ls24.

3. Bin Stock per Material

UseOverview about the Material bin stock all over the different Storage types

PrerequisitesThe Materials is maintain for the Warehouse Management and stock is at the storage

Procedure1. Access the transaction choosing one of the following navigation options:

Menu Logistics Logistics Execution Internal Whse Processes Bins and Stocks Display Bin Stock per Material

Transaction code LS24

2. On the Stock Overview screen, enter the necessary data.

Field name Description User action and values Comment

Warehouse number

Warehouse number YP1

Material Material Number <Material Number>

Plant BP01

3. Choose Enter.

4. On the Stock per Material screen, double-click Storage Bin.

The Storage bin details are displayed in the screen Display Storage Bin.

5. On the Stock per storage bin area, select the Material line an choose Quant

The detail about the Quant is displayed.

ResultThe completely bin stock from one Material over all storage types is displayed.

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Regulated Manufacturing (SAPyrin) (P09)

PurposeThis Building Block describes the manufacturing of batch and recipe products in process industries. The example used here is tablet production, which includes following manufacturing steps:

- Active ingredient production (PH-2400)

- Pharmaceutical production (PH-2500)

- Pharmaceutical packaging (PH-2600)

- Final packaging (PH-6501, PH-6502, PH-6503, PH-6504)

Creating and Releasing Process Orders

In general process orders can be created manually (which is described here) or they can be converted from the Stock & Requirement List after having carried our an MRP run. If the conversion is preferred skip this chapter and proceed with the release (if converted order is NOT released so far) or Process Management (if release and control recipe creation are done already).

1. Access the transaction choosing one of the following navigation options:

Menu Logistic Production–Process Process Order Process Order Create With material

Transaction code COR1

2. On the initial screen, enter the necessary data.

Field name Description User action and values Comment

Material number

PH-2400 or PH-2500, PH-2600,.PH-6501, PH-6502, PH-6503,PH-6504

Production plant

BP01

Process order type

YP01

3. Choose Enter.

4. On the Create Process Order: Header - General Data screen, enter the necessary data.

Field name Description User action and values Comment

Total qty(for PH-2400)

Production quantity 1000 KG Fixed qty

Total qty(for PH-2500)

Production quantity 240000 PC Enter a value between 240000 and 2400000 PC

Total qty Production quantity 24000 PC Enter a value between

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(for PH-2600) 24000 and 240000 EA

Total qty(for PH-6501)

Production quantity 5000 PC Enter a value between 5000 and 50000 EA

Total qty(for PH-6502)

Production quantity 2000 PC Enter a value between 2000 and 20000 EA

Total qty(PH-6503)

Production quantity 1000 PC Enter a value between 1000 and 10000 EA

Total qty(for PH-6504)

Production quantity 100 PC Enter a value between 100 and 1000 EA

Finish/Start Scheduling date Date Select one scheduling type

For the manufacturing of PH-2500 three production versions exist (the number of production versions depends on activated Building Blocks!).

Production version Master Recipe used Remarks

0001 MR-12001/1 Dispensing carried out in the PI-Sheet

0002 MR-12002/1Dispensing carried out at the external Weighing System (Building Block P12 required!)

0003 MR-12011/1Dispensing carried out in the PI-Sheet but approved recipe (with ECM) used (Building Block P41 required!)

5. Choose Enter.

6. Accept the information message indicating that the master recipe used is not subject to required approval (This messages comes up only if Building Block P41 Engineering Change Management is NOT activated!).

In the pharmaceutical industry, master recipes, that are subject to approval as well as process orders, that are subject to individual approval are used. This is a prerequisite for the electronic batch record EBR (Building Block P13).

The master recipes that are used to manufacture above materials are not subject to approval (if P41 not installed!), even though this is required by the used process order type YP01. For this reason, the system expects an individual approval for the order release and the acceptance of the information message.

7. Choose from menu Process order Functions Approval Individual approval.

8. Choose Materials and on the Create Process Order: Material List screen release the order by choosing Release (Ctrl + F6). Batch determination and creation of control recipe are carried out automatically.

9. Save your entries.

For releasing a process order which already exists use following steps:

1. Access the transaction choosing one of the following navigation options:

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Menu Logistic Production–Process Process Order Process Order Change

Transaction code COR2

2. On the initial screen, enter the necessary data.

Field name Description User action and values Comment

Process order

Your PO number

3. Choose Enter.

4. Choose Release (Ctrl + F6).

5. Save your entry.

ResultWhen the process order is opened, material reservations for the required material components are created automatically or the specifications are transferred from the planned order. Purchase requisitions are created for material components or services that have to be procured externally. Capacity loads occur at the resources where the order is executed. The planned costs are also determined.

Process Order Execution/ Process ManagementWhen a process order is executed, actual data is required that documents the process flow, and is available for processing in SAP ERP components, as well as in external functional modules such as process control systems. Process messages are communication structures that are pre-defined in Customizing, and are used to transfer this data from process control to the various destinations. They can be used in systems that are controlled automatically or manually.

After a process order has been released for production, the process instructions defined in the order during process management are grouped together to form control recipes. They are then transferred via an interface to a distributed control system, or displayed in natural language on the screen as a PI sheet for a process operator.

In return, process management copies process messages from the process control level, which are transferred to various destinations. For example, actual values for the process can be transferred to process data documentation and evaluation functions; material consumption or production yields can be posted as a stock movement, and quality data can be reported to results recording in Quality Management.

1. Sending Control RecipesA control recipe contains all the information on the execution of a process order required by a particular control instance. Control recipes are created from the process instructions in the process order. They are created and transferred to process control after the process order or appropriate phases of the process order have been released for production. Control recipes can be created for distributed control systems or manual processing on the screen.

For more transparency the control recipes are NOT sent automatically in SAP Best Practices for Pharmaceuticals on purpose. It is therefore necessary to send the control recipes manually.

1. Access the transaction choosing one of the following navigation options:

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Menu Logistics Production–Process Process Management Control recipe Control recipe monitor

Transaction code co53

2. On the Control Recipe Monitor: Initial screen, enter the necessary data.

Field name

Description User action and values Comment

Plant < your plant > e.g. BP01

Process order

your process order

3. Choose Display.

4. On the Control Recipe Monitor: Overview screen select the corresponding control recipes for your process order and choose Send. After processing choose Refresh.

Depending on the material to be produced and production version used different number of control recipes were created:

- PH-2400: 1 Control recipe for destination 10

- PH-2500, Production version 0001: 2 Control recipes for destinations 11 and 12

- PH-2500, Production version 0002: 2 Control recipes for destinations WS and 12

- PH-2600: 1 Control recipe for destination 13

- PH-6501/PH-6502, PH-6503, PH-6504: 1 Control recipe for destination 14

2. Processing PI sheets

As of release R/3 4.70 Enterprise SAP provides the Soft-Log-on functionality.

It allows using a group user of user type Service for system access. For processing the PI sheet and/or the Process Manufacturing Cockpit it is then absolutely necessary to logon with a user ID of user type Dialog. This functionality can also be used if process steps will be carried out by different persons (user change in the PI sheet).

To evaluate this topic create a user of user type Service in the transaction su01. Log on to the system. Call up PI sheets as described below. For processing the PI sheet use Log on (Shift + F8).

In a PI sheet, the process instructions contained in a control recipe are formatted for display and maintenance on the screen. The PI sheet enables information to be exchanged between PP-PI and process operators in an entirely or partially manually-controlled system.

Depending on the process instructions in a control recipe, the PI sheet supports the following functions:

Output of control information in natural language

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Recording actual data on the process

Carrying out calculations

Confirming the entered and calculated values using process messages

Recording inspection results by branching directly to QM

Calling user-defined functional modules to trigger a dialog or read data from internal and or external applications

In SAP Best Practices for Pharmaceuticals only browser-based PI sheets are used.

As of release 4.6C, the SAP ERP System provides the option of working with either ABAP list-based or browser-based PI sheets. Using the control recipe destination type in Transaction o10c, you can convert the PI sheets from the familiar format (ABAP list-based) to the standard layout of the browser-based PI sheet.

We highly recommend using the browser-based PI sheet.

1. Access the transaction choosing one of the following navigation options:

Menu Logistics Production–Process Process Management PI sheet Find

Transaction code co60

2. On the Find PI sheet screen, enter the necessary data.

Field name

Description User action and values Comment

Plant < your plant > e.g. BP01

Process order

your process order

3. Choose Execute (F8).

4. On the Find PI Sheet screen select the corresponding PI sheet(s) for your process order and choose Maintain PI sheet (F5).

Depending on the production version used different number of PI sheets were created:

- PH-2400: 1 PI sheet

- PH-2500, Production version 0001: 2 PI sheets

- PH-2500, Production version 0002: 1 PI sheet

- PH-2600: 1 PI sheet

- PH-6501/PH-6502, PH-6503, PH-6504: 1 PI sheet

Evaluate all possibilities of used PI sheet in the given order (use links, confirm process steps, call SOP’s etc.) and read introductions in the following chapters upfront (chapter HUM and Material Identification (P15) and chapter QM in Production (P32)). Finally complete the PI sheets.

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In SAP Best Practices for Pharmaceuticals, the digital signature is carried out using the ERP user ID and the corresponding password.

7. Choose Complete after confirming the End of PI sheet and go back in order to process the additional PI sheets (if others available).

3. Sending process messages

For more transparency the process messages are NOT sent automatically in SAP Best Practices for Pharmaceuticals. It is therefore necessary to send the process messages manually.

1. Access the transaction choosing one of the following navigation options:

Menu Logistics Production–Process Process Management Message Message monitor

Transaction code co54

2. On the Process Message Monitor: Initial screen, enter the necessary data.

Field name

Description User action and values Comment

Plant < your plant > e.g. BP01

Process order

your process order

3. Choose Message list.

4. Select the process messages you have created in the previous step and choose Send.

4. Evaluating Logs for Digital SignatureSAP provides a tool which allows to display the logs for digital signatures. Whenever digital signatures (e.g. during processing of PI sheets or results recording or archiving of an electronic batch record) were carried out the activity can be checked in transaction dsal.

1. Access the transaction choosing one of the following navigation options:

Menu Cross Application Components Engineering Change Management Reporting Log for Digital Signature

Transaction code DSAL

2. On the Digital Signature Logs Screen, enter the necessary data.

Field name

Description User action and values Comment

Applicatn SHEET – PI sheet or EBR –Batch record or LOT – Inspection lot

Signatory < user ID > optional

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Depending on the selection above tabs in the lower part of the screen require additional values.

3. Choose Execute.

4. On the Display logs screen detailed information is available.

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Process Manufacturing Cockpit (P14)

The Process Manufacturing Cockpit will be accessed by maintaining a PI sheet (Transaction co60) !

As of release 4.6C SAP ERP offers the possibility of designing individual Process Manufacturing Cockpits in Process Management.

Basing on the XML technology companies can set up their own cockpit which includes useful information for the so called paperless production.

SAP Best Practices for Pharmaceuticals delivers a Process Manufacturing Cockpit with a company logo, links to company homepages (intranet), links to internet, documents as additional, process order independent information for production. It is even possible to call up standard transactions within the ERP system, send order related messages and to play video clips as important description for complex process steps.

The Process Manufacturing Cockpit will be loaded automatically if Building Block P14 is activated.

SAP Best Practices for Pharmaceuticals provides Internet links that allow you to display the options in the Process Manufacturing Cockpit. The Internet links were available at the time this example was developed. If the links are not available at the time of use, make the corresponding changes in the file.

Evaluate all possibilities of the PMC (use links, call SOP’s, watch the movie clip etc.)!

Visit the web sites of our development partners!

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HUM and Material Identification (P15)

PurposeHandling Unit Management is a functionality which originally comes from Sales and Distribution area.

In combination with Material Identification (which can be carried out in different ways) SAP Best Practices for Pharmaceuticals shows a powerful and safe application for the use in the pharmaceutical industry.

Creation of Handling Units for Manufacturing

PrerequisitesAfter successful activation of the Building Block P15 a process order (for PH-2500) must be created already. The control recipe must be sent and the corresponding PI sheet must be created and loaded.

Procedure1. In the PI sheet for a process order for PH-2500 navigate to phase 0030 and choose Picking.

2. On the Picking for Manufacturing Order screen (dynamic function call to transaction copawa) select the Open Reservations tab page which contains the material reservations for the process order.

3. Select all reservations (lines where batches were determined) and choose Copy.

4. After transferring the items to the Materials view enter a packaging material PH-0001 or PH-0002 in the field PackMaterials.

5. Select each item and choose Pack.

As it is standard in pharmaceutical production, use one handling unit per material and reservation, even though SAP ERP allows for different combinations when creating handling units.

6. Save your entries and you will go back to the PI sheet automatically.

7. Continue processing the PI sheet and send process messages in order to be able to carry out material identification.

Completeness Check and Sequence Check

PrerequisitesHandling units must be created and all corresponding process messages must be sent already (transaction co54).

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Procedure1. In the PI sheet for a process order for PH-2500 navigate to phase 0060 and choose

Completeness check.

2. On the Material Identification: Completeness screen enter the handling unit IDs in the Handling Unit field and choose Enter. The system automatically recognizes all handling units and confirms that they belong to the process order.

For presentations that highlight material identification in practice, it is highly recommended that you present material identification using the barcode scanner. Connect the barcode scanner using a keyboard wedge.

3. Save your entries after identification of all handling units and you will go back to the PI sheet automatically.

4. Navigate to the phase 0080 (0100 and 0180 respectively) and choose Sequence check.

5. On the Material Identification: Sequence screen enter the handling unit ID which belongs to the phase (preconfigured by assignment of materials to certain phase in the BOM) in the Handling Unit field and choose Enter. The system automatically confirms that it belongs to the particular phase.

For presentations that highlight material identification in practice, it is highly recommended that you present material identification using the barcode scanner. Connect the barcode scanner using a keyboard wedge.

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Material Reconciliation (P16)

PurposeThe American Food and Drug Administration (FDA) requires a material reconciliation for pharmaceutically relevant materials used in the process order.

This requirement has been realized in SAP Best Practices for Pharmaceuticals through the definition of a process instruction (derived from a standard process instruction) and its integration to a phase in the used master recipe.

Additionally a class was defined and the materials used for the manufacturing of PH-2500 (PH-1610, PH-1620, PH-1630, PH-1640 and PH-2400) were assigned to the class type 050 (standard as of Release 4.6C)

Furthermore, the definition of a formula for reconciliation in Customizing is required and a value range must be entered.

In Customizing, a simple formula is defined with which the relationship is calculated between the required quantities and the quantities actually used 98-102 % applies as the value range.

PrerequisitesProcess order is created and control recipe is sent already. PI sheet is created and processed so far. Process messages are sent for all process steps (=phases in the PI sheet) and goods movements that have been carried out.

Procedure1. In the PI sheet for a process order for PH-2500 navigate to the final phase 0210 and choose

Material reconciliation.

2. On the Material reconciliation screen (transaction mircmr) goods movements are displayed for the process order and material flows are compared and documented according to the defined formula.

3. Choose Back (F3) for returning to the PI sheet.

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Electronic Batch Record (P13)

Purpose

To record the electronic batch records the mySAP ERP system has to be connected to a so-called optical archive (write-once-read-multiple-principle)!

However, for demonstration purposes (ONLY!) it might be useful to archive in the database. In this case refer to SAP Notes 595563 and 685521.

The Electronic Batch Record implemented in SAP Best Practices for Pharmaceuticals contains all the quality relevant plan and actual data concerning the production of a batch. Batch records are stored forge-proof in an optical system and can then be approved using one or more digital signatures. They are in accordance with international standards for processing records as defined in the GMP (Goods Manufacturing Practices) guidelines for the pharmaceutical industry.

A batch record consists of a current valid version and, possibly, a history. The history is a documentation of previous versions that became invalid because an addition was made to the batch record after its approval. All versions with their status are kept in the batch record’s header.

PrerequisitesTo generate, archive and approve an electronic batch record a few prerequisites must be fulfilled

- The Batch record required indicator has to be set for the material to be produced (material master; Work scheduling view).

- A suitable process order type was chosen.

- Master recipes requiring approval or process orders requiring individual approval must be used!

- The relevant process order has to be technically completed (menu path: Process order Functions Restrict processing Technically complete).

- All PI sheets have to have the discarded, terminated or completed status.

- Inspection close has to be complete for all inspection lots belonging to the order (inspection lot status: ICCO), the lot lock for the batch record has to be set (inspection lot status: LOLK), the usage decision has to be made (not for inspection type 04) (inspection lot status: UD).

Since creation of process orders, sending control recipes, processing PI sheets and finally sending process messages are described in previous chapters in detail only the fulfillment of requirements are explained here!

All semi-finished and finished materials of this value chain (PH-2400, PH-2500, PH-2600, PH-6501, PH-6502, PH-6503 and PH-6504) require an electronic batch record.

Setting inspection close in QM1. Access the transaction using:

Menu Logistics Quality Management Quality Inspection

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Inspection Lot Usage Decision Record

Transaction code QA11

2. On the Record Usage Decision: Initial screen, enter required inspection lot number (You can get the inspection lot number from the process order -transaction cor3- on the Assignment tab page) and choose Enter.

3. Force the inspection completion by entering following data:

Field name

Description User action and values Comment

Expiration date

date in the future

UD code A (Accept) This step can only be carried out for lot origin 03, but not 04

4. Complete inspection by following Edit Inspection completion Complete.

5. Set block for batch record by following Usage decision Functions Block for batch record Set.

6. Save your entries.

Make sure that all inspection lots created by the process order (type 03 and 04) have the particular status.

Completing process order technically1. Access the transaction using:

Menu Logistics Production–Process Process Order Change

Transaction code cor2

2. Enter your PO number and choose Enter.

3. Set process order to technically completed by following Process order Functions Restrict processing Technically complete.

4. Save your entry.

Generating batch record1. Access the transaction using:

Menu Logistics Production - Process Process Management Environment Process Orders Tools Process Data Document Batch Record

or

Logistics Production - Process Process Orders Tools Process Data Document Batch Record

Transaction code coebr

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2. On the Batch record: Create worklist screen, enter following data (You can get the batch number from the process order -transaction cor3- on the Goods receipt tab page)

Field name

Description User action and values Comment

Batch your batch number

Material your material number

Plant your plant

3. Select Generating and choose Execute.

4. On the Generate batch record screen, place the cursor on your batch and choose Batch record.

Archiving and approving batch record1. Access the transaction using:

Menu Logistics Production - Process Process Management Environment Process Orders Tools Process Data Document Batch Record

or

Logistics Production - Process Process Orders Tools Process Data Document Batch Record

Transaction code coebr

2. On the Batch record: Create worklist screen, enter following data (You can get the batch number from the process order -transaction cor3- on the Goods receipt tab page)

Field name Description User action and values Comment

Batch your batch number

Material your material number

Plant your plant

3. Select Displaying/Changing and choose Execute.

4. On the Display batch record screen, choose Switch between change mode and display mode.

5. Choose Archive, confirm the upcoming Deviation screen and save the archiving process.

6. Choose Approve, confirm the upcoming Deviation screen.

7. Write a comment on the upcoming Signature screen and carry out the digital signature (ERP User-ID and password).

8. Save your entries.

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ResultYou have fulfilled all requirements and generated, archived and approved a batch record for a produced batch.

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Integration of Weighing System (P12)

PurposeThis Building Block introduces the data exchange between SAP ERP and the external Weighing System via the PI-PCS interface. In order to show the capabilities of this scenario it is necessary to use the SAP module PP-PI.

The scenario starts with creating a process order where the batch determination is carried out. After sending the resulting control recipe to the weighing system the so-called weighing order will be processed at the Weighing System. The Weighing System creates the corresponding process messages automatically and sends them back to the ERP system.

The integration of the weighing system is integrated in the manufacturing of the tablet PH-2500. In order to ease the procedure an existing master recipe is copied and modified for the use with the weighing system.

Creating Process Orders

Procedure1. Access the transaction using:

Menu Logistic Production–Process Process Order Process Order Create With material

Transaction code COR1

2. On the initial screen, enter the necessary data.

Field name Description User action and values Comment

Material number PH-2500

Production plant BP01

Process order type YP01

3. Choose Enter.

4. On the Create Process Order: Header - General Data screen, enter the necessary data.

Field name Description User action and values Comment

Total qty(for PH-2500)

Production quantity 240000 PC Enter a value between 240000 and 2400000 PC

Finish/Start Scheduling date Date Select one scheduling type

For the manufacturing of PH-2500 three production versions exist (the number of product versions depends on activated Building Blocks!).

Production version Master Recipe used Remarks

0001 MR-12001/1 Dispensing carried out in the PI-Sheet

0002 MR-12002/1 Dispensing carried out at the external Weighing System (Building Block P12

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required!)

0003 MR-12011/1Dispensing carried out in the PI-Sheet but approved recipe (with ECM) used (Building Block P41 required!)

5. Choose Production version and select the required production version 0002 !

6. Choose Enter.

7. Accept the information message indicating that the master recipe used is not subject to required approval.

In the pharmaceutical industry, master recipes that are subject to approval as well as process orders that are subject to individual approval are used. This is a prerequisite for the electronic batch record EBR (Building Block P13).

The master recipe 1 from recipe group MR-12002, that is used to manufacture PH-2500 is not subject to approval (on purpose), even though this is required by the used process order type YP01. For this reason, the system expects an individual approval for the order release and the acceptance of the information message.

8. Choose from menu Process order Functions Approval Individual approval.

9. Choose Material list and on the Create Process Order: Material List screen release the order by choosing Release (Ctrl + F6). Batch determination and creation of control recipe are carried out automatically.

10. Save your entries.

Sending Control RecipesA control recipe contains all the information on the execution of a process order required by a particular control instance. Control recipes are created from the process instructions in the process order. They are created and transferred to process control after the process order or appropriate phases of the process order have been released for production. Control recipes can be created for distributed control systems or manual processing on the screen.

Be advised that the process order generates two control recipes. After processing the weighing order at the weighing system the PI sheet must be completed.

For more transparency the control recipes are NOT sent automatically in SAP Best Practices for Pharmaceuticals. It is therefore necessary to send the control recipes manually.

1. Access the transaction using:

Menu Logistics Production–Process Process Management Control recipe Control recipe monitor

Transaction code co53

2. On the Control Recipe Monitor: Initial screen, enter the necessary data.

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Field name

Description User action and values Comment

Plant < your plant > e.g. BP01

Process order

your process order

3. Choose Display.

4. On the Control Recipe Monitor: Overview screen select the corresponding control recipes for your process order and choose Send. After processing choose Refresh.

Processing weighing orders at weighing systemProceed according to the instructions at the weighing system.

Sending process messages (of weighing system)

For more transparency the process messages are NOT sent automatically in SAP Best Practices for Pharmaceuticals. It is therefore necessary to send the process messages manually.

1. Access the transaction using:

Menu Logistics Production–Process Process Management Message Message monitor

Transaction code co54

2. On the Process Message Monitor: Initial screen, enter the necessary data.

Field name

Description User action and values Comment

Plant < your plant > e.g. BP01

Process order

your process order

3. Choose Message list.

4. Select the process messages you have created in the previous step and choose Send.

Processing PI sheetIn a PI sheet, the process instructions contained in a control recipe are formatted for display and maintenance on the screen. The PI sheet enables information to be exchanged between PP-PI and process operators in an entirely or partially manually-controlled system.

Depending on the process instructions in a control recipe, the PI sheet supports the following functions:

Output of control information in natural language

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Recording actual data on the process

Carrying out calculations

Confirming the entered and calculated values using process messages

Recording inspection results by branching directly to QM

Calling user-defined functional modules to trigger a dialog or read data from internal and or external applications

In SAP Best Practices for Pharmaceuticals only browser-based PI sheets are used.

As of Release 4.6C, the SAP ERP System provides the option of working with either ABAP list-based or browser-based PI sheets. Using the control recipe destination type in Transaction o10c, you can convert the PI sheets from the familiar format (ABAP list-based) to the standard layout of the browser-based PI sheet.

We highly recommend using the browser-based PI sheet.

1. Access the transaction using:

Menu Logistics Production–Process Process Management PI sheet Find

Transaction code co60

2. On the Find PI sheet screen, enter the necessary data.

Field name

Description User action and values Comment

Plant < your plant > e.g. BP01

Process order

your process order

3. Choose Execute (F8).

4. On the Find PI Sheet screen select the corresponding PI sheet for your process order and choose Maintain PI sheet (F5).

Although 2 control recipes were created only 1 PI sheet will be available.

The processing of the PI sheet is described in previous chapters. The difference is that the handling units are created at the weighing system automatically and the handling unit IDs are sent to the SAP ERP system via the interface PI-PCS. During completeness check and sequence check those IDs will be identified.

Sending process messagesFor sending of process messages coming from PI sheet refer to previous chapters.

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Batch Information Cockpit (P03)Batch Information Cockpit is a powerful standard tool which enables you to collect, display and change data for batch managed materials.

1. Access the transaction using:

Menu Logistics Central Functions Batch Management Batch Information Cockpit

Transaction code bmbc

2. On the Batch Information Cockpit screen you will find the Selection area. The field selection in this area was configured by SAP Best Practices for Pharmaceuticals. The selection fields are:

Batch

Batch restricted (=Batch status)

Material

Material type

Plant

Storage location

Shelf life expiration date

Date of production

Last goods receipt

3. Make an entry in one or more selection fields (e.g. Plant and Material) and choose Execute.

4. Batches which match with the selection criteria will appear in the Selection results for batches area.

5. Select an appropriate batch from the list and get details on the batch using the batch master.

6. For changing the batch master choose Display <-> Change and save your entries before leaving the transaction.

Since the Batch Information Cockpit is a standard tool we highly recommend to refer to the SAP ERP standard documentation.

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Expiration Date Calculation (Batch derivation) (P17)The functionality of Batch Derivation was available after a separate activation in SAP R/3 4.6C and has become standard in SAP R/3 Enterprise 4.70 .

This Building Block allows to transfer batch master data and classification data of the component batches of produced batches. During batch derivation it is possible to forward and change important batch data depending on the manufacturing level. Following basic rules apply:

-Component batches may send data

-Produced batches may receive data

SAP Best Practices for Pharmaceuticals shows how this functionality can be applied using materials of material type FERT as receiving batch and materials of material types HALB, ROH and YPPM as sending batches.

In general the Batch Derivation should be carried out as last activity in the manufacturing process.

PrerequisitesBatch-where used list must be set up for the plant where derivation will be carried out.

Manual derivation1. Access the transaction using:

Menu Logistics Central Functions Batch Management Batch Derivation Manual derivation

Transaction code dvman

2. On the Manual Derivation of Batch Data screen, enter the necessary data.

Field name Description User action and values Comment

Material PH-6501 or PH-6502, PH-6503, PH-6504

Batch < batch number >

Plant BP01 your plant

Maximum batch number

100

Use only FERT materials (= recipients) in order to carry out batch derivation. HALB materials are not configured as recipients!

3. Choose Execute (F8).

4. On the Manual Derivation of Batch Data – Plant BP01 – Display Batch screen select the required batch in the Selection results area.

5. Choose Perform Derivation.

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6. In case of derivation the Results of derivation screen comes up indicating that derivation was carried out successfully.

7. For results of derivation choose Details.

8. On the Derivation: Detail View screen an overview of sent and received data is available.

Batch derivation during batch record generation

In general the Batch Derivation should be carried out as last activity in the manufacturing process, depending on a companies’ strategy. This is according to SAP standard delivery the derivation event ‘100 (Usage decision)’. However this event allows Batch derivation only in hidden mode.

SAP Best Practices for Pharmaceuticals therefore shows the derivation during batch record generation on purpose.

PrerequisitesA process order must be available and technically completed. In addition all prerequisites must be fulfilled in order to be able to generate an electronic batch record.

Procedure1. Access the transaction using:

Menu Logistics Production - Process Process Management Environment Process Orders Tools Process Data Document Batch Record

Transaction code coebr

2. On the Batch record: Create worklist screen, enter following data (You can get the batch number from the process order -transaction cor3- on the Goods receipt tab page).

Field name Description User action and values Comment

Batch your batch number

Material your material number

Plant your plant

3. Select Generating and choose Execute.

4. On the upcoming screen Result of derivation indicates that batch derivation was carried out.

5. Choose Details in order to get to Derivation: Detail view where additional information is available.

6. Choose Back and Continue saving (Enter).

7. Proceed with batch recording as indicated in previous chapters.

The results of Batch Derivation can be checked in transaction dvmo. On the Derivation: Monitor screen de-flag ‘Current Derivations Only’ before choosing Execute.

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SAP OPC Data Access and Alert Management (P27)

Use

Based on the industry standard OLE for Process Control (OPC), SAP offers the SAP OPC Data Access (SAP ODA) component. It supports data exchange between SAP ERP and process control systems from different vendors. SAP ODA can be used to receive items (data points) and events from the process control level automatically or on request and write values in the SAP ERP System.

In addition, SAP ODA comprises a number of different functions for system administration. One of the components of SAP ODA is the SAP ODA Connector, which is located outside the SAP System.

It is highly recommended to refer on the SAP ERP Enterprise documentation on SAP ODA.

SAP Best Practices for Pharmaceuticals has designed three typical cases in order to show how SAP OPC Data Access can be used.

-Sending messages (as SMS or as e-Mail) from Process Manufacturing Cockpit

-Reading values from a Process Control System during manufacturing process and sending messages (as SMS or as e-Mail) from according PI sheet

-Subscribe values and generate messages automatically.

Be advised that all messages (SMS and emails) will be sent to the user which was created during activation of Building Block P27. Make sure that the assignment is carried out and that all data (pager number and email address) are maintained. If you want to receive the messages in your e-Mail account or on your own mobile phone assign your user to the alert categories.

The SAP ERP Enterprise must be connected to an SMS/Fax server in order to send an SMS.

The delivery type (SMS or email) can be selected by using the program Z_SET_ALERT_DELIVERY in the transaction se38 or by using the parameter transaction /SMB10/T001_P27. This can be done anytime.

Selecting delivery type for alerts

PrerequisitesProgram Z_SET_ALERT_DELIVERY is installed.

Procedure1. Access the transaction using:

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Transaction code /SMB10/T001_P27

2. On the Set delivery type for alert (SMS or email) screen select the delivery type (Email or SMS).

3. Choose Execute (F8).

Sending messages from PMC (manually)

PrerequisitesThe Process Manufacturing Cockpit (Building Block P14) must be activated and a PI sheet must be processed.

Procedure1. Access the transaction using:

Menu Logistics Production–Process Process Management PI sheet Find

Transaction code co60

2. On the Find PI sheet screen, enter the necessary data.

Field name

Description User action and values Comment

Plant < your plant > e.g. BP01

Process order

your process order any process order that uses browser-based PI sheet

3. Choose Execute (F8).

4. On the Find PI Sheet screen select the corresponding PI sheet for your process order and choose Maintain PI sheet (F5).

5. Before selecting Complete for the PI sheet (!) enter a message in the Process Manufacturing Cockpit.

Field name

Description User action and values Comment

Process order number

<your process order> in the Entry area of the Cockpit

Message text

any text maximum number of characters is 255

There are two different Complete buttons on the screen!

6. Select Complete for the message (!) and proceed with processing the PI sheet.

7. Choose Complete after confirming the End of PI sheet and go back in order to process the additional PI sheets (if others available).

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Besides the process message categories that were created by the activities on the PI sheet an additional process message category YP_TREAD will be created as a result of message generation in the cockpit.

8. Send that particular process message category by using this transaction:

Menu Logistics Production–Process Process Management Message Message monitor

Transaction code co54

9. On the Process Message Monitor: Initial screen, enter the necessary data.

Field name

Description User action and values Comment

Plant < your plant > e.g. BP01

Process order

your process order

10. Choose Message list.

11. Select all process message categories from the PI sheet and the process message category from the cockpit and choose Send.

12. The message will be sent automatically in the background.

For sending emails or short messages the user master of sender must be maintained with both email address and a pager number.

Getting values from PCS and sending messages (automatically)

Getting values from PCS is embedded in the master recipe PH-12001!

PrerequisitesAn OPC (demo) server must be installed.

A process order for the material PH-2500 which uses the master recipe PH-12001 (Production version 0001) must be available (= released and saved), control recipe must be created and sent, and a PI sheet must be generated.

Procedure

1. Access the transaction using:

Menu Logistics Production–Process Process Management PI sheet Find

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Transaction code co60

2. On the Find PI sheet screen, enter the necessary data.

Field name

Description User action and values Comment

Plant < your plant > e.g. BP01

Process order

your process order any process order that uses browser-based PI sheet

3. Choose Execute (F8).

4. On the Find PI Sheet screen select the corresponding PI sheet for your process order for the material PH-2500 and choose Maintain PI sheet (F5).

5. Process the PI sheet taking the given sequence into consideration and navigate to the phase 0190 Perform coating and use OPC.

6. Choose Read Temperature via OPC and check the value which comes from the demo OPC server installed during Building Block P27 activation.

The value comes from OPC server. The second increment of the current time (e.g. 11:30:28) is chosen as source. All values above 30 will be relevant for messages!

7. You can select the pushbutton several times until a value between 30 and 59 comes up.

8. Finish the activity for the phase with your signature as usual and go ahead with processing the PI sheet as described in previous chapters.

9. Send all process message categories by using this transaction:

Menu Logistics Production–Process Process Management Message Message monitor

Transaction code co54

10. On the Process Message Monitor: Initial screen, enter the necessary data.

Field name

Description User action and values Comment

Plant < your plant > e.g. BP01

Process order

your process order

11. Choose Message list.

12. Select all process message categories from the PI sheet and choose Send.

13. The message will be sent automatically in the background.

For sending emails or short messages the user master of sender must be maintained with both email address and a pager number.

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Subscribe values and generate messages automatically

PrerequisitesAn OPC (demo) server must be installed.

Procedure1. Access the transaction using:

Menu Logistics Production–Process Process Management Message Create Automatically

Transaction code co69

2. On the upcoming Plant screen enter BP01 in the Plant field and choose Enter.

3. On the Automatic Process Message Creation: Overview Plant BP01 screen choose Create Variant (Shift + F5).

4. On the Automatic Process Message Creation: Define Variant screen make following entries:

5. On the Find PI sheet screen, enter the necessary data.

Field name

Description User action and values Comment

Variant LEVEL_CHCK

Short text Level check

Start Condition

E (Event-Driven Start)

Event Use F4 Help !

6. As Event choose from menu Event OAE BP01 VESSEL_LEVEL_ALARM on the upcoming Choose Event screen and confirm with Enter.

7. Enter YP_LEVEL in the Message Category field and choose Enter.

8. After message characteristics are available make following entries (use F4 Help for Characteristic values!):

Field name ValAssType Characteristic Value

PPPI_DATA_POINT_NAME F (Fixed Value) MIXING VESSEL

PPPI_DATA_POINT_VALUE D (Data Point) ODA:BP01.VESSEL_LEVEL

PPPI_EVENT_DATE D (Data Point) SYS:DATE.LOCAL

PPPI_EVENT_TIME D (Data Point) SYS:TIME.LOCAL

PPPI_UNIT_OF_MEASURE F (Fixed Value) l

9. Save your entries and go back to the Automatic Process Message Creation: Overview Plant BP01 screen.

10. Select the newly created variant name and choose Start Variant (Ctrl + F6).

11. According to the Event severity which was set up in the transaction coopc1 values will come up from time to time. They generate the process message category YP_LEVEL.

12. Send all process message categories by using this transaction:

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Menu Logistics Production–Process Process Management Message Message monitor

Transaction code co54

13. On the Process Message Monitor: Initial screen, enter the necessary data.

Field name Description User action and values Comment

Plant < your plant > e.g. BP01

Proc. Message Cat.

YP_LEVEL

14. Choose Message list.

15. Select all process message categories from the PI sheet and choose Send.

16. The message will be sent automatically in the background.

For sending emails or short messages the user master of sender must be maintained with both email address and a pager number.

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Engineering Change Management (P41)

PurposeEngineering Change Management is a central logistics function that can be used to change various aspects of production basic data (e.g., BOMs, task lists, materials, and documents) with history (with date effectivity) or depending on specific conditions (with parameter effectivity).

In SAP Best Practices for Pharmaceuticals Engineering Change Management is used in order to have approved master recipes (bill of materials and production versions respectively). Master recipes which require approval is one of the prerequisites for the use of Electronic Batch Record in SAP ERP Enterprise.

SAP Best Practices for Pharmaceuticals comes with two sets of master recipes for the use in process orders. Consider that manual selection of production versions is required if Engineering Change Management P41 is activated!

Material to be produced

Production version

Used master recipe(Recipe group/recipe number)

PH-2400 0001 MR-11001/1 NO ECM

PH-2400 0002 MR-11011/1 with ECM

PH-2500 0001 MR-12001/1 NO ECM

PH-2500 0002 MR-12002/1 NO ECM

PH-2500 0003 MR-12011/1 with ECM

PH-2600 0001 MR-13011/1 NO ECM

PH-2600 0002 MR-13011/1 with ECM

PH-6501 0001 MR-14001/1 NO ECM

PH-6501 0002 MR-14011/1 with ECM

PH-6502 0001 MR-14002/1 NO ECM

PH-6502 0002 MR-14012/1 with ECM

PH-6503 0001 MR-14003/1 NO ECM

PH-6503 0002 MR-11013/1 with ECM

PH-6504 0001 MR-14004/1 NO ECM

PH-6504 0002 MR-14014/1 with ECM

Create Change Request

Procedure1. Access the transaction using:

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Menu Logistics Production – Process Master Data Engineering Change Management Change Number Create

Transaction code CC01

2. On the initial screen the radio button ECR has to be activated and the following data has to be entered.

Field name Description User action and values Comment

Change type Change type for change master

901

Profile Change profile YP_ECM01

3. Choose Enter and you get to the Create Engineering Change Request: Change Header screen. Fill the following fields.

Field name Description User action and values Comment

Change request description

< short text >

Valid From Valid from date < Valid from date > This field can be filled right now or later, the latest when converting the change request into a change order.

4. Choose Objects. Assign all master recipes which have to be changed with the change order to the tab page TL.

Field name Description User action and values Comment

TlstTy Task list type 2

Group Recipe Group < Recipe group >

Description Description < Short text > Optional entry

ChgTyp Change type for change object

< Change Type > Optional entry

5. Choose Enter before leaving the tab page TL.

6. Assign all bill of materials which have to be changed with the change order to the tab page Mat. BOM.

Field name Description User action and values Comment

Material <Material> Select the material that will be manufactured with the recipe chosen above.

Plant BP01

BOM Usage 1

Description BOM for XXXX Material from above

Change Type 1

7. Choose Enter before leaving the tab page Mat. BOM.

8. Navigate into the change request header (e.g. by choosing the button with the hat symbol).

9. Choose Set Status (pencil symbol with green mark) or run through the menu Edit Set Status.

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10. Choose Set Status (pencil symbol with green mark) with the description Check ECR again.

11. Choose Continue or Enter.

12. Save your change request.

ResultA change request has been created for your assigned master recipes and bill of materials.

Check Change Request

Procedure

1. Access the transaction using:

Menu Logistics Production – Process Master Data Engineering Change Management Change Number Change

Transaction code CC02

2. Check if the requested changes to the master recipes and bill of materials in the object view make sense.

3. There are three possibilities per object: the object change may be possible, unnecessary or impossible.

4. Mark all objects of one of these three categories on the object overview tab page (the first one).

5. Run through the menu Edit Object Status Change <variable>. <variable> means either Possible, Unnecessary or Impossible.

6. Objects for which it has been decided the change to be impossible, are set inactive. They still appear in the object view, but is not considered any longer within the status control of the change request / change order. It will not be possible to change these objects with reference to this change request / change order.

7. Objects for which it has been decided the change to be unnecessary, are still active. As long as one object is in this state, the change request cannot be converted into a change order.

8. Objects which can be changed, will be active during the further processing of the change request / change order.

9. Navigate into the change request header (e.g. by choosing the button with the hat symbol).

10. Choose Set Status (pencil symbol with green mark) or run through the menu Edit Set Status.

11. Choose Set Status (pencil symbol with green mark) with the description ECR Checked again.

12. Choose Continue or Enter.

13. Save your change request.

ResultThe change request now has the status CHKD (checked).

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Approve Change Request and Convert it into a Change Order

Procedure1. Call up the transaction as follows:

Menu path Logistics Production – Process Master Data Engineering Change Management Change Number Change

Transaction code CC02

2. Choose Set Status (pencil symbol with green mark) or run through the menu Edit Set Status.

3. Choose Set Status (pencil symbol with green mark) with the description Approve ECR again.

4. Choose Set Status (pencil symbol with green mark) with the description Convert ECR again.

5. The signature dialog box appears. The Comment is optional. The logon password has to be entered, to perform the electronic signature.

6. Choose Continue or Enter .

7. Save your change request. At the latest now the Valid From date in the change order header has to be filled.

ResultThe change request is approved and converted into a change order. Now changes to the objects are possible with this change number, if they have been categorized change possible.

Perform Changes to Master Recipes and Bill of Materials

PrerequisitesA change order with the status CHKD ECRA ECOP is required.

Procedure1. Call up the transaction as follows:

Menu path Logistics Production – Process Master Data Master Recipes Recipe and Material List Change

Transaction code C202

2. Enter the required data on the Change Master Recipe: Initial Screen.

Enter your change order number in the field Change Number in the frame Validity.

3. Enter the master recipe and perform your planned changes to the master recipe and the bill of material, as requested within the change request.

4. Save your changes.

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ResultYour master data have been changed, as requested within the change request.

Assign Change Number to Production Version

PrerequisitesA change order with the status CHKD ECRA ECOP is required. This step is only relevant, if approved production versions are required.

Procedure1. Call up the transaction as follows:

Menu path Logistics Production – Process Master Data Production Versions

Transaction code C223

2. Enter the required data into the upper (selection) frame of the Production Version: Mass Processing screen and choose Enter.

3. Mark the production version(s) within the table at the bottom of the screen.

4. Choose Assign change number below the table.

5. Enter the change number of the change order, confirm your entry and choose Consistency check.

6. Save your changes.

ResultYour master data have been changed, as requested within the change request.

Complete and Release Object Changes

Procedure1. Call up the transaction as follows:

Menu path Logistics Production – Process Master Data Engineering Change Management Change Number Change

Transaction code CC02

2. Choose Objects.

3. Mark all objects of one of these two categories on the object overview tab page (the first one).

4. Run through the menu Edit Object Status <variable> Change. <variable> means either Complete or Incorrect.

5. In case of incorrect change(s), the corresponding master data has to be corrected.

6. Finally all objects should be in the status change completed.

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7. Mark all objects on the object overview tab page (the first one).

8. Run through the menu Edit Object Status Release Change.

9. Save your change request.

ResultAll object changes are now released in the object view.

Close and Release Change Order

Procedure1. Call up the transaction as follows:

Menu path Logistics Production – Process Master Data Engineering Change Management Change Number Change

Transaction code CC02

2. Choose Set Status (pencil symbol with green mark) or run through the menu Edit Set Status.

3. Choose Set Status (pencil symbol with green mark) with the description Close ECO again.

4. Choose Set Status (pencil symbol with green mark) with the description Release ECO again.

8. The signature dialog box appears. The Comment is optional. The logon password has to be entered, to perform the electronic signature.

9. Choose Continue or Enter.

5. Save your change order.

ResultThe change order is released and inactive, no changes can now be performed any longer to the change order and with the change order. The changes to the belonging master data will be active starting with the Valid From date.

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QM in Production (P32)

PurposeIn the pharmaceutical industry, all materials in production are subject to strict checks. Some of these checks are carried out by post-process-controls, and some by in-process-controls.

When a goods receipt from production has been posted, the ERP System creates an inspection lot, which must be processed.

Production of Solid Dosage Forms - In-Process control (from PI sheet)As an example for the so called QM jump during processing of a PI sheet for PH-2400 three process instructions are included in the master recipe MR-11001/1 (Phase 050). They lead to appropriate pushbuttons in the PI sheet. Selecting them allows the QM jump.

The New sample – optional pushbutton. You can create a new physical-sample drawing in case more samples are required in addition to the samples generated automatically. The Create New Physical-Sample Drawing with Reference transaction is called and the relevant fields Inspection lot, Number of samples, Physical-sample category and Sample quantity are pre-assigned. You can start the physical-sample creation by choosing Execute (F8). The system displays a report on the created samples. Afterwards you can branch back to the PI sheet choosing Back (F3).

The Display sample & print label pushbutton. You can branch to an existing physical-sample drawing to release the samples (not necessary in this scenario) or to print labels. You branch to the Process Physical-Sample Drawing transaction. You can start the label output choosing Label.

The Insp. Results rec. pushbutton. You can branch to the results recording for in-process controlling by choosing this pushbutton. You branch to the transaction for results recording. If there are several samples for the IPC inspection lot, the system then requests that you enter the sample required. You can determine the samples for the inspection lot using the search help (F4) for the Sample field. Then for the Content of acid characteristic, enter a measured value in the Results field and choose Enter to trigger the valuation of the characteristic (accept or reject). Save the results to branch back to the PI sheet.

In the master recipe MR-12001/1 process instructions are included for phase 195 that lead to the following pushbuttons in the PI-sheet:

The Insp. Results rec pushbutton leads you to the result recording transaction for the inspection characteristics assigned to operation 170 in the master recipe. By choosing assigned insp. Pnt. the list of inspection points that already have been created is displayed. In this example inspection points are created automatically depending on the scheduled time for the operation and the time-factor defined for the operation. Select an inspection point from the list and enter a shift-ID. (Note : In customizing it is possible to define different fields (date, time, numeric, text) for the identification of inspection points. In this example shift-id (18 digit character), drawing date and drawing time are used for the inspection point identification.) After choosing Enter the result recording for the inspection point is started. The system requires 3 single values for the Content of water and 3 single values for the Weight Tablet characteristic. After you enter the last value and choose Enter, the system automatically valuates and closes the characteristic. If the specification is violated (rejection), you are to enter a inspection description. Repeat the jump to the result recording several times for the remaining inspection points, to create data for the control charts.

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The Check CC: Water content pushbutton calls the transaction for displaying control charts. The selection field for inspection characteristic is filled so that the chart for the characteristic Water content is displayed. Start the selection, mark the line with the inspection lot number you entered results for in the previous step and start the control chart. By choosing the button with the calculator the control limits are calculated and displayed in the control chart. By choosing the button with the lock the control chart is closed.

The Check CC: Tablet weight provides the same functionality as described in the previous section for the characteristic Content of water.

Production of Solid Dosage Forms - In-Process control

1. Results RecordingWhen tablets are produced (as loose goods) samples are drawn from production and examined. As a rule, several in-process controls (IPC) are carried out, and an additional post-process control is carried out at the end of the production process when several samples (including a reserve sample) are drawn.

In SAP Best Practices for Pharmaceuticals, this scenario can be worked through using SAPyrin tablets as an example. During the production process, an IPC is carried out with inspection points in which the characteristics accompanying production are checked. The system generates inspection points automatically for the operations for which inspection characteristics have been determined in the master recipe. The time interval between the inspection points is controlled via the Time factor field in QM Data for Operation. The number of inspection points results from scheduling of operations and the time factor.

In a subsequent step, the tablets are then packed and sold as the actual finished product.

Prerequisites

PH-2500 (SAPyrin tablets) in plant BP01 is subject to QM. In the material master, inspection type 03 is active.

In the recipe header under QM data, the inspection is activated with generated inspection points.

Inspection characteristics are defined in the master recipe (recipe group MR-12001); the time-based inspection is activated and a time factor is maintained in the QM Data for Operation view. For phase 150 (In-Process Control Tablets), the Appearance inspection characteristic is defined and a time factor of 60 minutes is specified in the QM Data for Operation. For operation 170 (Coating), the Content of water and the Weight tablet SPC inspection characteristic are defined and a time factor of 180 minutes is specified.

The process order belonging to the recipe is released. When the process order is released, an inspection lot is created automatically for the in-process control (inspection type 03), and the inspection points for the inspection lot are generated automatically. The inspection points are available in the work list for results recording.

Procedure1. Call the transaction as follows:

Menu path Logistics Quality Management Quality Inspection Worklist Results Recording

Transaction code QE51N

2. Enter the required data on the Results Recording Worklist screen.

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Field name Description User action and values Comments

Plant Plant number BP01

Material Material number PH-2500

Insp.lot origin Type of inspection lot (in this case, in-process control)

03

Batch Batch number Relevant batch number, if known

3. On the upcoming Inspection Point screen make following entry:

Field name Description User action and values Comments

Shift ID Identifier of the shift that carried out the results recording

Enter text or number The date and time fields of the inspection point identification have been automatically filled during generation.

Alternatively, you can also record results for the operation directly:

Menu path Logistics Quality Management Quality Inspection Inspection Results For Operation Record

Transaction code QE01

Field name Description User action and values Comment

Insp. Lot Inspection lot number

Appropriate inspection lot number (In-process lots beginning with 300000...)

Search using F4 input help (for order, for batch, etc.)

Plant Plant number BP01

Char. filter Determines which characteristics are displayed

1 – All characteristics

Operat. Operation of the QM characteristic

150 or 170 (130 or 160 if Weighing System is installed)

Results for operation 170 may be recorded as well by using the QM-Jump functionality from the PI-sheet.

After you choosing Enter, the system requests you enter the inspection point identification (shift identification) and the operation. Enter a text or number as shift identification and the required operation (0150).

ResultsOperation 150:

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In the overview, you only need to enter the number of the inspected samples and the code. When you choose Enter, the system valuates and closes the characteristic. By saving the results, you have to enter your digital signature (ERP user and password).

Field name

Description User action and values Comment

Inspected Number of inspected sample

5

Results Result for characteristic appearance

01 (for OK) Comes from selected set

Operation 170:

The system requires 3 single values for the Content of water and 3 single values for the Weight Tablet characteristic. After you enter the last value and choose Enter, the system automatically valuates and closes the characteristic. If there is an error in the specification (rejection), you are to enter a inspection description. By selecting the characteristic and choosing Control chart, it is possible to display the control chart for the SPC characteristic. When you save, the system requests your digital signature a second time.

2. Quality Notifications - Defect RecordingIf there is a specification error for the Content of water characteristic, the system automatically creates a quality notification of notification type F3 – Material-rel. defect with a defect item of the defect type Content of water too high. If the notification is not activated manually, the system automatically closes it when you make the usage decision.

In addition to the automatic generation of quality notifications for specification errors, you also have the option to record defects manually from results recording. Via the SAP menu (Logistics Quality Management Quality Inspection Defects), you can record defects for the inspection lot, the operation or the characteristic. The defect data records are stored in a quality notification.

The Impure raw material defect in the YP-P code group is defined as a critical defect which triggers a workflow (if activated). If you choose this code for defects recording, then all the users, who are defined in Customizing as a responsible employee, are notified per express mail that a critical defect has occurred (see the Customizing QM Documentation). These users then find a work item in their Business Workplace; this work item allows them to branch to notification processing directly.

3. Recording the Usage DecisionWhen results recording is complete, the usage decision for the material can be made. This normally corresponds to the in-process control releasing of the semi-finished product for packing.

PrerequisitesThe inspection results for the inspection lot have been recorded, valuated, closed and saved.

ProcedureYou can branch directly from results recording (see previous point: Transaction qe51n) to the usage decision by double-clicking the top line of the inspection lot (on the left-hand side of the screen) after you have saved the results.

1. Alternatively, call up the transaction as follows:

Menu path Logistics Quality Management Quality Inspection Inspection Lot Usage Decision Record

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Transaction code QA11

2. Enter the required data on the Record Usage Decision screen.

Field name Description User action and values Comment

Inspection Lot Number of inspection lot

Enter inspection lot number or search using F4

3. Enter the usage decision code on the next screen.

Field name Description User action and values Comment

Selected set 03 Production

UD Code UD Code description

A (Acceptance)

ResultsThe results for the inspection point are saved.

In-process control inspection lots (inspection type 03) are not relevant for stock. The valuation of the results cannot be linked to a stock posting.

If you complete them before the corresponding process order is technically completed, the system displays a corresponding information message.

You should also consult the standard SAP ERP documentation on this point.

If some of the inspection results have not been recorded, valuated, or closed, the system informs you that there are inspection characteristics still open. If this is the case, go back to the results recording function and carry out these actions, or force inspection completion (by confirming the appropriate message).

An electronic batch record is required for material PH-2500. The lot lock for the batch record has to be set (inspection lot status: LOLK). It is only possible to archive the record if the usage decision has been made for the IPC inspection lot.

Production of Solid Dosage Forms - Post-Process control (with Sample Management)

1. Results RecordingWhen tablets are produced (as loose goods) samples are drawn from production and examined. As a rule, several in-process controls (IPC) are carried out, and an additional post-process control is carried out at the end of the production process, when several samples (including a reserve sample) are drawn.

In SAP Best Practices for Pharmaceuticals, this scenario can be worked through using SAPyrin tablets as an example. With goods receipt from production, 5 samples are drawn which are examined for specific characteristics. From these, two pooled samples are created, and a

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reserve sample is also drawn. The samples are assigned to a batch, and are released; results for the individual samples are recorded and the release of the inspection lot is made.

In a subsequent step, the tablets are then packed and sold as the actual finished product.

PrerequisitesIn the material master, inspection type 04 is active.

A corresponding sample-drawing procedure is created (sample-drawing procedure YP-02).

The post-process control is carried out with an inspection plan. The sample-drawing procedure is entered in the inspection plan, after the samples have been created.

Sampling procedures (YP-S13) for inspection points/sample management have to be assigned to the characteristics in the inspection plan.

When the process order is confirmed, an inspection lot for the post-process control (inspection type 04) is automatically generated and samples are created.

The system is configured so that the goods are confirmed via production and not via QM.

Procedure1. First, you have to release the physical-sample drawing. Call the transaction as follows:

Menu path Logistics Quality Management Quality Inspection Sample Management Physical-Sample Drawing Edit

Transaction code QPR4

2. On the selection screen, use F4 to search for the correct physical-sample-drawing number (search help via material or inspection lot or batch).

Field name Description User action and values Comment

Plant Plant number BP01

Material Material number PH-2500

3. Select the physical-sample-drawing number; mark all the entries, and choose Release in the menu bar.

4. You can then record the results via the work list.

Menu path Logistics Quality Management Quality Inspection Worklist Results Recording

Transaction code QE51N

5. Enter the following data on the selection screen:

Field name Description User action and values Comment

Plant Plant number BP01

Material Material number PH-2500

Insp.lot origin Type of inspection lot (in this case,

04

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post-process control)

Batch Batch number Relevant batch number, if known

6. The system provides the appropriate inspection lots and samples for processing.

Alternatively, you can also record results for the operation directly:

Menu path Logistics Quality Management Quality Inspection Inspection Results For Operation Record

Transaction code QE01

Field name Description User action and values Comment

Inspection Lot Inspection lot number

Appropriate inspection lot number (post-process lots beginning with 400000...)

Search using F4 input help (for order, for batch, etc.)

Plant Plant number BP01

Char. filter Determines which characteristics are displayed

1

Operation Operation of the QM characteristic

0010 (for visual inspection)0020 (for lab analysis)

After you choosing Enter, you are requested to select a physical sample, and to enter descriptive text for the physical sample and the operation.

Select the physical sample using F4 Help, and enter a text or number as identification, and the above operations (for example, 0010).

ResultsYou branch to results recording. The following operations have to exist:

0010 Identity with the characteristics friability and tablet printing

0020 Lab analysis with the characteristics active ingredient content and weight of tablet

In the overview, you only have to enter the number of samples inspected and the code or numeric value according to the specification in the inspection lot (for example, 26% or 2.0 g).

Field name Description User action and values Comment

Inspected Number of inspected sample

1 or 5

Results Result for characteristic appearance

01 (for OK)

Enter a result, valuate it and close it. Afterwards, save the operation.

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2. Recording the Usage DecisionWhen results recording is complete, the usage decision for the material can be made. Normally, this corresponds to releasing the semi-finished product for packing.

When the acceptance usage decision is saved, the material is automatically posted to unrestricted stock in ERP. In all other cases (with transfer postings, rejections, or similar activities), items have to be posted manually from within the usage decision.

PrerequisitesThe inspection results for the inspection lot have been recorded, valuated, closed and saved.

ProcedureYou can branch directly from results recording (see previous point: Transaction qe51n) to the usage decision by double-clicking the top line of the inspection lot (on the left-hand side of the screen) after you have saved the results.

1. Alternatively, call up the transaction as follows:

Menu path Logistics Quality Management Quality Inspection Inspection Lot Usage Decision Record

Transaction code QA11

2. Enter the required data on the Record Usage Decision screen.

Field name Description User action and values Comment

Inspection Lot Number of inspection lot

Enter inspection lot number or search using F4

3. Enter the usage decision code on the next screen.

Field name Description User action and values Comment

Selected set 04 Goods receipt from production

UD Code UD Code description

A (Acceptance)

Batch status Batch Status Set to unrestricted stock

The system displays the dialog box automatically when you save the usage decision.

Change from restricted to unrestricted.

ResultsThe material is posted to the unrestricted stock. Only then can it be used for the subsequent packing order.

The usage decision code is written in the batch classification automatically (for example, A for acceptance). You can check to see if this is the case in Transaction msc3n (Display batch, enter material, plant and batch number).

If some of the inspection results have not been recorded, valuated, or closed, the system informs you that there are inspection characteristics still open. If this is the case, go back

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to the results recording function and carry out these actions, or force inspection completion (by confirming the appropriate message).

At this level of the batch for semi-finished products, you can specify the country for which the batch can be used (based on your analytical results, for example). To do this, proceed as follows:

1. Call the transaction as follows:

Menu path Logistics Materials Management Material Master Batch Change

Transaction code MSC2N

2. Find the appropriate batch; choose Enter, and then choose Classification in the upper menu bar. Select the following from the suggested characteristics:

Field name Description User action and values Comment

Characteristic YP_VALID_FOR_COUNTRY

Enter country Use standard country abbreviations.

ResultsThe batch classification has been changed.

An electronic batch record is required for material PH-2500. Inspection close has to be complete for all inspection lots belonging to the order (inspection lot status: ICCO), the lot lock for the batch record has to be set (inspection lot status: LOLK).

Pharma Packing - Post-Process control

1. Results RecordingThe tablets are packed In a separate production step with a special process order. In our example, when packing is completed, quality control draws samples, which are examined for certain characteristics, such as whether the leaflet is correct, the packaging is undamaged, and so on. Additionally, GMP requires the production and analysis documentation to be complete before the product can be released for sale.

Four different sizes of package are manufactured:

PH-6501 SAPyrin Tablets (20 EA)

PH-6502 SAPyrin Tablets (50 EA)

PH-6503 SAPyrin Tablets Doc. sample

PH-6504 SAPyrin Tablets (10 x 50 Clinical)

PrerequisitesThe materials PH-6501, PH-6502, PH-6503, and PH-6504 are subject to QM. In the material master, inspection type 04 is active. An inspection plan is assigned to the material.

A goods receipt from production (confirmation) has been posted.

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ProcedureYou record the results of the created inspection lot via the results recording work list.

1. Call the transaction as follows:

Menu path Logistics Quality Management Quality Inspection Worklist Results Recording

Transaction code QE51N

2. Enter the required data on the Results Recording screen.

Field name Description User action and values Comment

Plant Plant number BP01

Material Material number PH-6501

Insp.lot origin Type of inspection lot (in this case, post-process control)

04

Batch Batch number < batch number >

Alternatively, you can also record results for the operation directly:

Menu path Logistics Quality Management Quality Inspection Inspection Results For Operation Record

Transaction code QE01

Field name Description User action and values Comment

Inspection Lot Inspection lot number

Appropriate inspection lot number (post-process lots beginning with 400000...)

Search using F4 input help (for order, for batch, etc.)

Plant Plant number BP01

Char. filter Determines which characteristics are displayed

1 – All characteristics

Operation Operation of the QM characteristic

0010 (for weight inspection)0020 (for packaging)0030 (for documents)

ResultsYou then branch to results recording. The following operations have to exist:

0010 (for weight inspection) characteristic: Weight of 20 PC package (ONLY FOR MATERIAL PH-6501)0020 (for packaging) characteristic, package content;0030 (for documents) characteristics: Analytic test reports; country indicator

In the overview, you only have to enter the number of samples inspected and the code or numeric value according to the specification in the inspection lot.

Enter a result, valuate it and close it. Afterwards, save the operation.

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The characteristic country code, that can be valuated directly from QM, is linked directly to a corresponding batch characteristic (Country indicator); this means that when valuation is carried out in results recording, the batch is automatically classified. As of Release 4.6B, a material specification no longer has to be maintained in this case (only one field in the material master).

3. Recording the Usage DecisionRefer to the steps described in the previous chapter.

ResultsIn the case of acceptance, the material is automatically posted to the unrestricted stock.

The usage decision code is written in the batch classification automatically (for example, A for acceptance). You can check to see if this is the case in Transaction msc3n (Display batch, enter material, plant and batch number).

In the case of a rejection, the material has to be posted manually.

If some of the inspection results have not been recorded, valuated, or completed, the system informs you that there are inspection characteristics still open. If this is the case, go back to the results recording function and carry out these actions, or force inspection completion (by confirming the appropriate message).

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WM Integration (P06)

PurposeThe Warehouse Management (WM) application component is interfaced to the Production Planning Shop Floor Control (PP-SFC) application component to assist in providing materials to supply areas in production. The significant advantage for customers using this WM-PP interface is that it provides pinpoint accuracy in timing the supply of materials to production storage bins in production supply areas.

The basic concept is for workers in production to be able to order needed materials themselves, which, in turn initiates the creation of transfer requirements in WM. Warehouse Management component, then, is responsible for supplying needed materials to the storage bins in production. It does so by creating a transfer order for each respective transfer requirement. This is part of the standard WM procedure.

The subsequent goods issue posting reduces the stock quantity of materials that have been removed from production storage bins and no additional activities are required in WM.

Material Staging

For each material and production supply area in a plant, you must clearly define the storage bins to which the necessary materials will be supplied and the type of material staging that will be implemented. This is known as a control cycle.

Advantages

You can request material staging in advance so that the required materials are supplied using WM (transfer requirement / transfer order) at the correct time. Also, no further activity is required for the consumption posting.

Prerequisites

When you use the WM component the assignment of plant and storage location to a warehouse number and from plant and warehouse number to storage location must be clearly established.

Using WM for material staging requires care and strict discipline in system handling. Materials may only be used for production by removing them from production storage bins that were defined for that purpose. If the needed stock is located in another location, it must be moved from that location to the production storage bin, because it is from that bin that the consumption posting will take place. If this practice is not consistently adhered to, the efficient use of the system will be significantly hindered by the increase in unnecessary stock differences.

Staging Materials for Production

PrerequisitesA production order is released and the staging in WM is not triggered.

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1. Create Transfer OrderIf the process order is released and the staging in WM is triggered start the scenario here.

1. Call up the transaction as follows:

Menu path Logistics Logistics Execution Internal Whse Processes Transfer Requirement Display For Storage Type

Transaction code LB10

2. Enter the required data on the screen Display Transfer Requirement: List for Storage Type.

Field name Description User action and values Comment

Warehouse number

Warehouse number YP1

Dest. storage type

Destination storage type

100 Production Supply

Enter

all Production Supplies deliveries are displayed

Select your Production Supply

TO in foregr. Click button Ctrl+Shift+F8

3. Enter the required data in the screen Create TO from TR: Overview of Transfer Requirement

Field name Description User action and values Comment

Generate TO item

Click button F6

4. Choose Post.

ResultThe transfer order is created

2. Confirm Transfer Order1. Call up the transaction as follows:

Menu path Logistics Logistics Execution Inbound Process Goods Receipt for Inbound Delivery Putaway Confirm Transfer Order Single Document In One Step

Transaction code LT12

2. Enter the required data in the Confirm Transfer Order: Initial Screen.

Field name

Description User action and values Comment

TO number <Transfer order number>

Warehouse number

Warehouse number YP1

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3. Choose Enter.

4. Enter the required data in the screen Confirm Transfer Order: Overview of TO Items.

Field name

Description User action and values Comment

Confirm internally

Click button F5

5. Choose Post.

ResultThe system contains a confirmed transfer order. The material is at the interim Storage 100. The production can use the staged material. Check the stock using the transaction ls24.

3. Bin Stock per Material

UseOverview about the material bin stock all over the different storage types.

PrerequisitesThe materials are maintained for the Warehouse Management and are available in the storage location.

Procedure1. Access the transaction using:

Menu Logistics Logistics Execution Internal Whse Processes Bins and Stocks Display Bin Stock per Material

Transaction code LS24

2. On the Stock Overview screen, enter the necessary data.

Field name Description User action and values Comment

Warehouse number

Warehouse number YP1

Material Material Number < Material Number >

Plant BP01

3. Choose Enter.

4. On the Stock per Material screen, double-click Storage Bin.

The Storage bin details are displayed in the screen Display Storage Bin.

5. On the Stock per storage bin area, select the Material line an choose Quant.

The detail about the Quant is displayed.

ResultThe completely bin stock from one material over all storage types is displayed.

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Putaway from produced materialFor a goods receipt an order to the placement of stock into the Warehouse is needed.

PrerequisitesA goods receipt for process order in the inventory management must be carried out. Stock is on interim storage type 917. The stock is released by a inspection lot from Quality Management.

1.Create Transfer Order1. Call up the transaction as follows:

Menu path Logistics Logistics Execution Internal Whse Processes Transfer Requirement Display For Storage Type

Transaction code LB10

2. Enter the required data in the screen Display Transfer Requirement: List for Storage Type.

Field name Description User action and values Comment

Warehouse number

Warehouse number YP1

Source storage type

Source storage type 917 Quality assurance

Enter

All open Transfer Requests are displayed.

Select your Transport Request for your Order

TO in foregr. Click button Ctrl+Shift+F8

3. Enter the required data in the screen Create Transfer Order for TR xxx: Prepare for putaway.

Field name Description User action and values Comment

Puttaway foreground

Click button F5

4. Enter the required data in the screen Create Transfer Order from TR: Generate Transfer order Item.

Field name Description User action and values Comment

Destination Destination <Destination Type>

Section Section <Destination Section>

Enter Check entrys

Enter

Post Click button Ctrl+S

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ResultThe transfer order is created

2. Confirm Transfer Order1. Call up the transaction as follows:

Menu path Logistics Logistics Execution Inbound Process Goods Receipt for Inbound Delivery Putaway Confirm Transfer Order Single Document In One Step

Transaction code LT12

2. Enter the required data on the Confirm Transfer Order: Initial Screen.

Field name Description User action and values Comment

TO number <Transfer order number>

Warehouse number

Warehouse number

YP1

Enter

3. Enter the required data on the screen Confirm Transfer Order: Overview of TO Items.

Field name Description User action and values Comment

Confirm internally

Click button F5

Post Ctrl.+S

ResultThe system contains a confirmed transfer order. The order goods are booked into the warehouse.

3. Bin Stock per Material

UseOverview about the material bin stock all over the different storage types.

PrerequisitesThe materials are maintained for the Warehouse Management and are available in the storage location.

Procedure1. Access the transaction using:

Menu Logistics Logistics Execution Inernal Whse Processes Bins and Stocks Display Bin Stock per Material

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Transaction code LS24

2. On the Stock Overview screen, enter the necessary data.

Field name Description User action and values Comment

Warehouse number

Warehouse number YP1

Material Material Number <Material Number>

Plant BP01 Not necessary

Enter Click button Enter

3. On the <Stock per Material> screen, double-click Storage Bin.

The Storage bin details are displayed in the screen Display Storage Bin.

4. On the Stock per storage bin area, select the Material line an choose Quant.

The detail about the Quant is displayed.

ResultThe completely bin stock from one material over all storage types is displayed.

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Sales and Distribution (P20)

PurposeThis Building Block describes the sales of batch drugs to domestic customers. In general this sales scenario can be used in the following areas, for example:

Solid dosage forms

Liquid dosage forms

Drugs available only from pharmacy

Drugs only available on prescription

Wholesale pharmacy

Hospital business

Direct sales pharmacy

To map the process flow for domestic sales of drugs, the goods in question must be in stock and ready for sale.

The corresponding master data (e.g. articles, prices, conditions, customers, batches) must be maintained in the system.

Process FlowThe process flow in this scenario essentially covers the following areas:

Sales support (contacts, requests for quotation, quotations, contracts)

Sales (sales order processing)

Shipping (warehouse management, transport, processed automatically in background)

Billing (invoice creation)

In the following, presales is not discussed explicitly, since in this particular area no sector-specific adjustments were carried out in Best Practices for mySAP Pharmaceuticals. The related processes can be covered completely by the standard ERP functionalities, which are explained in the standard ERP documentation.

In this scenario, orders are entered manually (without the use of EDI) by office-based sales personnel using the appropriate SAP ERP transaction.

Free goods processing is integrated in the present scenario. Depending on material and customer both exclusive and inclusive bonus quantity is available according to the table below:

Material Customer Bonus quantity type

PH-6501 C-1000 exclusive

PH-6501 C-1003 inclusive

PH-6502 C-1000 exclusive

PH-6502 C-1003 inclusive

PH-6504 C-1001 exclusive

PH-6504 C-1005 inclusive

Exclusive bonus quantity type means: For example order 100 EA, pay 100 EA, get 102 EA.

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Inclusive bonus quantity type means: For example order 100 EA, get 100 EA, pay 98 EA.

When an order is entered, an availability check and pricing are carried out using the prices and conditions stored.

The pharma central number (PCN) can be used instead of the material number. The pharma central number functions are described in detail in a separate document.

The value chain encompasses the following steps:

Order OR Standard order

Delivery LF Outbound delivery

Billing document F2 Invoice

At the end of the scenario the following documents are available with completed status:

Order

Delivery

Transfer order

Goods issue

Billing document

Follow-on documents are also generated for the areas

Financial accounting (not cleared)

Profitability analysis

Cost center accounting

Sales OrderWhen an order is entered, an availability check is performed for the material.

The corresponding free-goods discount (exclusive bonus quantity) is determined and added to the order as a free item using the order quantity.

The pricing data is determined using the standard pricing procedure RVAA01.

The pharma central number (PCN) or the European article number (EAN) can be entered instead of the material number. In both cases, the entry for the European article number is made via matchcode.

PrerequisitesThe required master data (e.g. articles, prices, conditions, customers, and free goods) must be maintained in the system.

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Reference can be made to any operations or master data from presales (quotations, requests for quotation, contract).

Procedure1. Call up the transaction as follows:

Menu path Logistics Sales and Distribution Sales Order Create

Transaction code VA01

2. Enter the required data in the Create Sales Order screen.

Field name Description User action and values

Comment

Order type OR Standard order

Sales organization BP01 Sales Org. BP01

Distribution channel 02 Wholesale

Division 01 Product Division 01

3. Choose Enter.

4. Enter the required data on the Create Standard Order screen.

Field name Description User action and values

Comment

Sold-to party C-1000 Apothekengroßhandel Schmölln

Purch. ord. no. 123/AB-45 Free text or SAP related purchase order number

Material PH-6501 SAPyrin (20 tablets)

Order quantity 100 2 products are added for free

5. Choose Enter and save your entries.

ResultA complete sales order is created in the system.

Shipping: Delivery (with WM)

Perform this activity only if the product to be shipped is WM managed (means if Building Block P06 is activated successfully) !

When the delivery is created, a new availability check is performed and automatic batch determination is carried out using the shelf life expiration date and the remaining shelf life of the batch.

PrerequisitesA complete sales order must be available before a delivery document can be created. Materials (and batches) must be available in the WM warehouse !

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Procedure1. Call up the transaction as follows:

Menu path Logistics Sales and Distribution Shipping and Transportation Outbound Delivery Create Single Document With Reference to Sales Order

alternatively:

Logistics Logistics Execution Outbound Process Goods Issue for Outbound Delivery Outbound Delivery Create Single Document With Reference to Sales Order

Transaction code VL01N

2. Enter the required data on the Create Outbound Delivery with Order Reference screen.

Field name Description User action and values

Comment

Shipping point BP01 Shipping point BP01

Selection date Selection date for the delivery

<Date>

Order Number of sales order

<Sales Order number>

3. Choose Enter.

4. Enter the required data in the Create Outbound Delivery: Overview screen and save your entries.

ResultThe system contains a complete delivery document.

Warehouse Management: Transfer Order for Delivery (same quantity)A transfer order is generated by Warehouse Management automatically to pick the delivery. The transfer order has to be confirmed before the goods issue can be posted.

PrerequisitesIn this scenario, the warehouse is managed using the Warehouse Management (WM) module. The Customizing for WM must be set accordingly in the system.

To process a delivery in the warehouse, the system must contain a complete delivery document.

The delivery was created, saved and transfer order is known.

UseA transfer order is generated in Warehouse Management to pick the delivery. The transfer order is then confirmed before the goods issue can be posted.

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PrerequisitesThe Delivery was created and saved. The Condition WMTA (for Items) is automatically created.

Procedure1. Access the transaction using:

Menu Logistics Logistics Execution Outbound Process Goods Issue for Outbound Delivery Picking Display Transfer Order For Material

Transaction code LT24

2. On the Transfer Orders for Material screen, enter the necessary data.

Field name Description User action and values Comment

Warehouse number

Warehouse number YP1

Material Material Number <Material Number>

Only open TO items

Flag Default

3. Choose Execute.

4. On the Transfer Orders: List for Material screen (The stock have to be the same quantity like the TO) proceed as follows.

Field name Description User action and values Comment

BP01 Select the row

4. Choose Confirmation in Background.

5. Repeat this procedure for every item in the transfer order.

ResultTransfer order is confirmed (see message below) and green sign (=). In the Stock Overview (transaction ls24) the material is shown on interim storage bin 916.

5. On the Transfer Orders: List for Material screen (The stock have not to be the same quantity like the TO).

Field name Description User action and values Comment

BP01 Mark the row

Confirmation Foreground

Click button Ctrl.+Shift+F8

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Warehouse Management: Transfer Order for Delivery (different quantity)

PrerequisitesThe Delivery was created and saved. The Condition WMTA (for Items) is automatically created. The stock have not to be the same quantity like the TO).

Procedure1. Access the transaction using:

Menu Logistics Logistics Execution Outbound Process Goods Issue for Outbound Delivery Picking Display Transfer Order For Material

Transaction code LT24

2. On the Transfer Orders for Material screen, enter the necessary data.

Field name Description User action and values Comment

Warehouse number

Warehouse number YP1

Material Material Number <Material Number>

Only open TO items

Flag Default

Execute Click button F8

3. On the Transfer Orders: List for Material screen. (The stock has not to be the same quantity like the TO) proceed as follows.

Field name Description User action and values Comment

BP01 Mark the row

Confirmation in Foreground

Click button Ctrl.+Shift+F08

4. On the Confirm Transfer Order: Confirm Single Item screen, enter the necessary data:

Field name Description User action and values Comment

Difference ind.

Different indicator Select an indicator

Confirmation indicator for destination subitem

S (Diff.quantity is difference between act. and targ.qty)

Actual quantity

Actual destination in alternative unit

Quantity of maesure

Enter Click button

In the Background the systems calculate the difference.

5. On the Confirm Item: Confirm Differences screen, carry out following activity:

Field name Description User action and values Comment

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Confirm difference

Click button F5

ResultTransfer order is confirmed (see message below) and red unequal sign ().

In the Stock Overview (LS24) the Material is shown on interim storage bin 916.

Create Transfer Order for remaining quantity1. Call up the transaction as follows:

Menu path Logistics Logistics Execution Outbound Process Goods Issue for Outbound Delivery Picking Create Transfer Order Single Document

Transaction code LT03

2. Enter the required data on the Create Transfer Order for Delivery Note: Initial Screen.

Field name Description User action and values

Comment

Warehouse number

Warehouse number

YP1

Plant Plant BP01 Not necessary

Delivery Number of delivery

<Delivery number>

Enter

3. On the Create TO for Delivery XXX: Prepare for Stock Removal screen, carry out following activity:

Field name Description User action and values

Comment

Stock Removal Background (pushbutton)

Alternative menu call:Edit Generate TO Item (F6)

Save alternatively: Ctrl + S

Transfer order created

4. Call up the transaction as follows:

Menu path Logistics Logistics Execution Outbound Process Goods Issue for Outbound Delivery Picking Confirm Transfer Order Single Document In One Step

Transaction code LT12

5. Enter the required data on the Confirm Transfer Order: Initial Screen.

Field name Description User action and values Comment

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TO number Number of transfer order

<Number TO>

Warehouse number

Warehouse number

YP1

Foreground /Background

Foreground Transaction flow visible

Adopt pick. quantity

1 Adopts picking quantity in the delivery

Confirmation Pick + transfer

6. Choose Enter.

7. Enter the required data on the Confirm Transfer Order: Overview of TO Items screen.

Field name Description User action and values

Comment

Confirm internally pushbutton

Alternative menu call:Edit Confirm internally (F5)

8. Choose Post.

ResultTransfer order is confirmed (see message below).

In the Stock Overview (transaction ls24) the Material is shown on interim storage bin 916.

If the delivery is posted, the stock on 916 is removed.

Shipping: Delivery

Perform this activity only if the product to be shipped is NOT WM managed (means if Building Block P06 is NOT activated) !

For samples an automatic batch determination takes place in the delivery.

PrerequisitesA complete sales order must be available before a delivery document can be created. Materials (and batches) must be available in the storage location !

Procedure1. Call up the transaction as follows:

Menu path Logistics Sales and Distribution Shipping and Transportation Outbound Delivery Change Single Document

alternatively:

Logistics Logistics Execution Outbound Process Goods Issue for Outbound Delivery Outbound Delivery Change Single Document

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Transaction code VL02N

2. Enter the required data on the Change Outbound Delivery with Order Reference screen.

Field name Description User action and values

Comment

Order Number of sales order

<Order number>

3. Choose Enter.

4. On the Outbound Delivery <Delivery number> Change: Overview screen, select Picking tab page, and enter the required data (order quantity). In case of batch material choose batch structure of the delivery item.

Be advised that quantities in the table below refer to material PH-6501 and customer C-1000. Consider information on free goods in the beginning of chapter Sales and Distribution.

Field name Description User action and values

Comment

ButtonBatch Structure

Only for batch materials

Picking Quantity 100

Hide batch structure

ButtonBatch Structure

Only for batch materials

Picking Quantity 2

Hide batch structure

5. Choose Save.

ResultThe goods are fully picked.

Goods Issue for DeliveryAfter the goods have been picked via a transfer order, the goods issue for the delivery is posted.

PrerequisitesTo post the goods issue for a delivery, the system must contain a transfer order that has been processed and confirmed. The goods must have already been picked in WM or manually.

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Procedure1. Call up the transaction as follows:

Menu path Logistics Logistics Execution Outbound Process Goods Issue for Outbound Delivery Post Goods Issue Outbound Delivery Single Document

Transaction code VL02N

2. Enter the required data on the Change Outbound Delivery screen.

Field name Description User action and values

Comment

Outbound delivery

Number of delivery <Delivery number>

3. Choose Post goods issue.

ResultThe goods issue for the delivery has been posted. The transfer order and goods issue document have completed status. A billing document can be created.

BillingOnce the goods issue has been posted, the delivery can be invoiced. The pricing data is transferred from the order. Only the taxes are redetermined when the billing document is created.

PrerequisitesA delivery with goods issue posting is required for billing.

Procedure1. Call up the transaction as follows:

Menu path Logistics Sales and Distribution Billing Billing document Create

alternatively:

Logistics Logistics Execution Outbound Process Goods Issue for Outbound Delivery Billing Billing document Create

Transaction code VF01

2. Enter the required data on the Create Billing Document screen.

Field name Description User action and values

Comment

Document Number of delivery <Delivery number>

3. Choose Execute (F8).

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4. Enter the required data in the screen Create Invoice: Overview - Billing items and save your entries.

ResultA billing document has been generated. The document has completed status.

The corresponding documents were generated for financial accounting, profitability analysis, and cost center accounting.

The accounting document has not been cleared. The document can be cleared by entering an incoming payment, for example (transaction code f-28).

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