MANUFACTURINGDOCUMENTS

QUALITY MANUAL

Testing Method

Note :•Blue: WI (standard, specification & procedure)•Red: Record

Product Destruction Record

Return Product Handling RecordRecall Record

Product Complaint Record

Batch Production Record

Distribution Record

Master productiondocument

Master Formula

Master Prod. ProcedureMaster Pack. Procedure

TYPE OF GMP DOCUMENTS

Specification/ Standard

S.O.P.

Validation Protocol Report

Work Protocol(WP)

Raw & packaging material

Bulk

Finished productTesting result record and report

Stability test record

Sampling record

Microbial and particle monitoring record

Equipment StatusMaterial Status Product Status

Identity/Label

Manufacturing Records• Master Formula Record• Batch Manufacturing Record

– Content– Format– Approval and Storage– Change Control

• In Process Controls, Specifications, and Results• Bulk Storage and Labeling

• Another type of documentation is the form used for recording data as it is taken during the performance of tasks, tests, or events.

• These are forms (datasheets, or data record forms), reports, batch processing records, and equipment log books.

• These documents provide the evidence that the raw materials, facility environment, the production process, and the final product consistently meet the established quality requirements.

• Record legibly in permanent ink

GMP RECORDS

Check whether control records are maintained for: a. Raw materials and primary packaging materials,

documenting disposition of : released materials rejected materials.

b. Manufacturing of batches, documenting the: kinds, lots and quantities of material used. processing, handling, transferring, holding and filling. sampling, controlling, adjusting and reworking. code marks of batches and finished products.

c. Finished products, documenting sampling, individual laboratory controls, test results and control status.

d. Distribution, documenting initial interstate shipment, code marks and consignees.

RECORDS MAINTENANCE

Finished product specification should include:

Designated name, and internal code reference if applicable

Master Formula number Description of finished product and its package details Qualitative and quantitative requirement with

acceptance limits Direction for sampling and testing, or reference to an

approved procedure Storage condition or precautions, if any Shelf life, if any Batch numbering requirement (including manufacturing

date or expiry date )

FINISHED PRODUCT SPECIFICATION

MASTER FORMULA The master formula should be available upon request. A printed master formula and manufacturing instructions for each

product must be prepared, endorsed, and dated by the owner, manager, or competent person delegated by management. Wherever possible a second competent person should check, reconcile, endorse, and date formula instructions.

The master formula can be divided by : processing master formula packaging master formula

Transcription from the master documents should be by photocopying or computer printout. A competent person should initial each document before issue to signify that it is complete, legible and appropriate. Instructions should preferably be printed.

• Should be prepared for each batch of product.• Each Batch Processing Record should include the following :

name of product batch or code number master batch formula and number brief processing process processing date and yield identity of individual major equipment & lines or location used records of cleaning of equipment used for processing as appr

opriate in-process control and laboratory results, such as pH and tem

perature test records any sampling performed during various steps of processing any investigation of specific failure or discrepancies results of examinations on bulk products

BATCH PROCESSING RECORD

The master processing documents should include at least the following : a. product nameb. batch size c. a description of the product (form, color, odor, etc)d. a list of all materials and the quantity to be used e. equipment to be used and processing location;f. theoretical or expected yield;g. adequate step-by-step directions for manufacture:

precautions to be taken with regard to product and personal safety

equipment to be used and how to clean it to prevent cross-contamination;

sequence of adding materials; mixing times, temperatures; in-process control and storage condition

PROCESSING MASTER FORMULA

BATCH PROCESSING RECORDThe manufacture of the batch must proceed in accordance with these documents, and the following must be included:a. the actual weights of materials and, where given, the unique

identifying number. These weights should, where possible, be independently checked, and both weigher and checker should initial the record sheet;

b. the initials of the operator or supervisor for each step immediately after it has been performed;

c. the actual yield;d. a record of all samples taken and the results of tests performed;e. the batch number which specifically identifies it and distinguishes it

from all other batches;f. where applicable, a date after which the product must not be used.

MFG Batch Record HeaderMANUFACTURING LOG SHEET M.F.# Title:___________________________________________________ Date Approved:_________________________Approved by:________________________________ Date Checked:__________________________Checked by:_________________________________ Replaces Page No.:_____________________Dated:______________________________________ Date Written:__________________________Written by:_________________________________ Mfg. Lot. No.:_________________________Mfg. Date:__________________________________ Batch Size: ___________________________Page: 1 of 10___________________________ Reproduction Reviewed for Accuracy: Date:__________

MFG Batch RecordPreliminary Precautions

PRELIMINARY PRECAUTIONS:

1. Check the resistance of the water to be Resistance used. Water resistance must be greater

than one megohm. Checked by: ________________ 2. Check all equipment for cleaning status stickers. Check Equipment Log Book for Checked by: ________________ appropriate entries. 3. Make sure all raw materials to be used are properly identified and are released for Checked by: ________________ use. 4. The Process Operator will check to see that all scales and/or balances of sufficient capacity and sensitivity are available for each weigh out required in the manufacturing Checked by___________________ operation. 5. The Process Operator will test for accuracy all scales and/or balances involved in the Tested by: __________________ manufacturing operation before any weighing is done. Checked by: _________________

Manufacturing Batch RecordProcessing Steps

5. While mixing with Sweep, ADD: INV NO. Purified Water XXX. Kg.

Date weighed_______________________ Gross______________________________ Tare ______________________________ Net _______________________________ Scale used_________________________ RMC No.____________________________ Nos. entered by____________________ Weighed by Checked by_______ Added by Checked by_______ Sweep on Checked by_______

------------------------------------------------------------------------------------- 6. Mix for 10 minutes with Sweep. Time started Checked by_______

Time finished Checked by_______ Sweep ON__________Checked by_______

Manufacturing Batch RecordSampling/Bulk Storage

Take one aseptic micro sample and two 4 oz. test samples from each drum as it is being filled. Record Net Weights:

Drum #1 Gross_________________kg Tare__________________kg Net___________________kg Scale Used______________________ kg Total Weight _kg Weighed by_______________________kg Checked by_______________________kg Date Time___________kg

Drum #2 Gross_________________kg Tare__________________kg Net___________________kg Scale Used______________________ kg Total Weight _kg Weighed by_______________________kg Checked by_______________________kg Date Time___________kg

Manufacturing Batch RecordYield Determination/Sign Off

Yield: Theoretical Yield:___________________________ Actual Yield: kg Calculate percentage yield . % Calculated by______________ Checked by_________________ If Yield is greater than 100% or less than 90% Production Supervisor will investigate and justify. Remarks ____________________________________________________________________ ____________________________________________________________________________ ____________________________________________________________________________ PRODUCTION AND CONTROL RECORDS REVIEWED AND APPROVED BY: PRODUCTION DATE___________ QUALITY CONTROL DATE___________

PACKAGING MASTER FORMULA• The master packaging documents must include at

least the following where applicable: a. the name of the product;b. the contents of the primary container by volume or

weight;c. a reference to the specification of all materials

required for the packaging and labelling of the product;

d. any special instructions or precautions, including area clearance check

e. Description of packaging process;f. In-process control, with sampling instruction; g. provision for calculation of yield or reconciliation.

• An accurate copy of the master packaging and labelling instructions must be made for each batch of product before it is manufactured.

• Should be prepared for each batch of product.• Each Batch Processing Record should include the following :

name of product batch & code number batch formula and brief packaging process packaging date Theoretical and actual yield identity of individual major equipment & lines or location used records of cleaning of equipment used for packaging process in-process control and laboratory results, such as volume and

product weigh packaging line clearance records Expiry date, if shelf life is less than 30 months any investigation of specific failure or discrepancies disposition and identity of quarantine label

BATCH PACKAGING RECORD

Packaging Records

• Packaging Records– Content– Format– Approval and Storage– Change Control

• In Process Controls, Specifications, and Results• Product Labels

– Preparation - Storage– Ordering - Inventory– Proofing - Dispensing– Acceptance - Reconciliation– Counting - Returns

LABELING SYSTEM• Labeling systems are used to identify :

the status of the material, product, equipment , laboratory reagent, or facility

restricted areas, and warning labels.

• There are 2 classes of labels : label for finished products label used within the factory to control process

• Reference standards (both primary and secondary) must be appropriately labeled and the issuance must be controlled

MATERIAL / PRODUCT NAME : …………..

QC TESTING REPORT NO : ………….. SIGN : ….....

TESTING DONE BY : ………….. DATE : ….....

EXPIRE DATE : …………..

RETESTING SHOULD BE DONE : …………..

QC DEPARTMENT

APPROVED / RELEASED

MATERIAL / PRODUCT NAME : ………….. TESTING DATE BATCH NO. : ………….. …………. SUPPLIER / PRINCIPLE NAME : ………….. SAMPLING BY QUANTITY : ………….. ………….

QC DEPARTMENT

BEING RETESTED MATERIAL / PRODUCT NAME : ………….. BATCH NO. : ………….. QC TESTING REPORT NO : ………….. SIGN : …..... TESTING DONE BY : ………….. DATE : ….....

QC DEPARTMENT

REFUSED / REJECTED

MATERIAL / PRODUCT NAME : ………….. BATCH NO : ………….. INTERNAL CODE : ………….. SIGN : …..... SAMPLING DONE BY : ………….. DATE : ….....

QC DEPARTMENT

QUARANTINE

PRODUCT STATUS LABELS

Record for each testing, assay result and release or rejection of starting materials, intermediates, bulk and finished product should be maintained.

QC record may consist of : date of test identification of the material supplier name date of receipt original batch number if any batch number quality control number quantity received date of sampling quality control results

QUALITY CONTROL RECORD

Quality Control Testing• Sampling• Labeling• Sample Control• Testing

– Methods– Specifications

• Result Handling• Out of Specification Result Handling• Approvals• Record Maintenance and Security

REFERENCES

1. ASEAN Guidelines for Cosmetic GMP (2003)

2. WHO EDM, Basic Principle of GMP: Documentation part 1 and 2 (2004)

3. Wirjadidjaja E.C, Good Documentation Practices, Jakarta (March 2005)

4. Soenardi F, Document Creation, Jakarta (March 2005)