Equipment, Facilities and Utilities Work Order and Change Control...

Document Title:

Document Information:

Document Number:

Revision:

Status:

Document Type:

Effective Date:

Vault:

OFFICIAL COPY

Cambridge Major Laboratories, Inc.

Standard Operating Procedure Revision: 05

SOP Number: SOP69408

SOP Subject: Equipment, Facilities and Utilities Work Order and Change Control SystemPage: 1 of 15

Equipment, Facilities and Utilities Work Order and Change Control System

1. Purpose:

TheguidancegiveninthisSOPcoverstheprocesstoevaluate,document,approveandimplementchangesandnon-routinemaintenanceactivitiestomanufacturingfacilities,utilities, equipment, laboratoryequipment, andcomputerizedsystems toensuretheyaremaintainedinasafeandcompliantstate.Thisdocumentisbasedontherequirementsof ICHQ7.

2. In&OutofScope:

2.1 In Scope This procedure describes the process used to evaluate, document, approve and implement changes to all new and existing manufacturing/packaging processes, utilities, equipment, computerized systems, facilities used to manufacture and store active pharmaceutical products and intermediates.

Documents and systems that may be impacted by a given change in any of these areas include, but are not limited to, all master documents, Drug Master File (DMF), validation, stability protocols and control systems.

Note: The quality systems (equipment, facilities, utilities, computer systems, etc.) listed in the previous paragraph will be referred as “Technical Equipment” in the remainder of this document.

2.2 Out of Scope The following change controls are out of scope of this procedure. Documentation changes which do not result in any corresponding engineering

change assessment are not covered in this document. Standard equipment repairs captured by the Work Order System. Example: “Like-

for-Like” parts replacement.

OFFICIAL COPY





3. DefinitionsRefertoAppendix1foralistingofdefinitions

4. RolesandResponsibilitiesAll individuals requesting a change request must be trained per SOP69408 to request a change in their respective area. Change requests must be submitted using the change request form.

4.1 Requestor

Any CML Employee may request a change. The responsibilities of the requestor include: Initiating the ECC request. Providing a clear description and rationale of the proposed of change. Development of the URS and DQ documents, when required, for new technical

equipment and modifications to existing technical equipment. Ensuring that a change is not implemented until the request has been approved and

signed by Quality Assurance. Assists with development of a schedule for execution of activities associated with the

change request. Coordinates the implementation of the approved change request. Pro-actively follows up on actions required to ensure the completion and close out of

the change request in a timely manner. Assists with the assembly of documentation needed for pre-and post-approval of

required change control documents.

4.2 Quality AssuranceThe Quality Assurance (QA) Department is the owner of the change control system and maintains the Change Control register file. QA assigns individual numbers for each change request and ensures that documented evidence exists for the assessment of each change submitted. Additionally QA tracks the change documentation and communicates proposals, amendments, approvals, rejections and close outs to all affected parties.

The Quality Assurance Department must perform the following assessments and approvals: Classifying the change as a Minor or Major Change. Ensures changes are not duplicated and do not adversely impact any other quality

system or impact other proposed changes. Take accountability that the impact of the change has been appropriately

evaluated, which includes, but are not limited to:o Ensuring that GMP conditions are maintained.o Ensuring that documentation is clear and complete.o Ensuring that appropriate reviews are complete.

OFFICIAL COPY





o Ensuring that appropriate equipment hold or product hold processes are implemented for any proposed change.

o Ensuring that validation status is maintained, and if not, appropriate re-validation activities are initiated.

o Ensuring that personnel are appropriately trained and the training isdocumented prior to change implementation.

o Evaluating if the stability program is impacted.o Evaluating External Customers/Suppliers impact.o Evaluating impact to approved written contracts and technical agreements of

Third Party Manufacturers, contractors or suppliers.o Determines if the proposed change impacts the Master Production Record.o Approving the change proposal before implementation (pre-approval).o Reviewing the ECC for accuracy and acceptability on completion to ensure

that all actions are completed.

4.3 Change ReviewersChanges are reviewed by a cross sectional team which may include Engineering, Metrology, Manufacturing, Project Management, Environmental Health & Safety (EHS), IT, Regulatory Compliance, R&D, QA, Analytical Sciences, Supply Chain, Technical Services and Validation.Change Reviewers are responsible for: Ensuring the ECC has been completed correctly and accurately. Reviewing and approving the URS, FRS, and DQ documents.

Subject matter experts within the Change Review group will determine impact to their areas of expertise. These include, but are not limited to: Determining if the proposed change has a regulatory submission impact. Ensuringdocumentssuchastechnicalspecifications,drawings,schematics,

materialsofconstruction,andsafetyissues,etc.areaddressed. Determinetheimpactofchangeonproducts,manufacturingprocesses,technical

equipment,andmanufacturingoperatingparameters. Determiningwhatinstrumentcalibration(s)arerequired. EnsuringallrelatedSOPsandMasterProductionRecordsarereviewedor

updatedaspartofthechange. Identifying if there are any safety issues associated with the change. Determining the impact of change on the current validated state of any previously

qualified technical equipment. Determine the impact of change to the current process or cleaning validations.

OFFICIAL COPY





5. WorkOrderChangesWork Orders are issued for repairs, modifications and installations which impact Technical Equipment. Work Orders (WO) are given a unique number and are tracked using anelectronic log. The WO log minimally includes WO#, description, date received, requestor, and date closed. This log is maintained by Engineering and Maintenance. This is a reference-only non-GMP document.

All non-routine work/changes, additions, replacements, and removal of Technical Equipment require either a WO or ECC, unless exempt per Section 6.

Work Orders DO NOT require an ECC when:o Changes are made to non-GMP Technical Equipment o The change is defined as “Like-for-Like”.o A Safety Abatement is issued to correct a non-compliant condition

potentially impacting employee safety.o Routine equipment calibrations and maintenance operations.

Work Orders REQUIRE an ECC when:o The change is not part of a routine preventative maintenance or

calibration. o The change is not a “Like-for-Like” change and the equipment being

installed does not have identical specification, function, and / or the same material of construction as the original equipment.

o The change is part of a project that involves validated equipment / systems, facilities, utilities or process control systems (PLC / HMI).

o Requires a document change / update – change to the P&ID, loop drawings, validation protocol, or SOPs.

6. ExemptionsQC Change parts and expendables exempt from the Work Order and Change Control Process are listed in Appendix 3.

Non-process controlling PCs and software – including by not limited to Microsoft upgrades, installations, trouble shooting on PCs not associated with process equipment.

OFFICIAL COPY





7. ProcedureNote: A flowchart of the ECC process is included in Appendix 2.

7.1 Initiating a Change Request The requestor initiates the Engineering Change Control (ECC) request. A Unique Identification Number is issued by QA and is used to track ECCs. The Unique Identification Number is recorded in Section 1.1 of FRM2974.

7.2 Change Request (Section 1.1)Section 1 of the change request form FRM2974 must be completed by the requestor.This section of form FRM2974 is composed of the following sections:

Change Request – State the building, equipment ID, owning department, location(room/area), requested by / date, proposed start date.

Type of Technical Equipment – Select the type of Technical Equipment impacted. Change Type - Select the type of change such as addition, modification, repair,

transfer, decommission of technical equipment. If the change is related to a Corrective Action / Preventative Action, record the CAPA number. Note: Decommission FRM3379 is also required for decommissioning of equipment.

Change requests are further categorized as Planned or Unplanned / Emergency Change. Planned Change Requests

o All changes that can follow a regular review and approval process, these are scheduled per area needs. The majority of changes are Planned Changes. For Planned Change Requests, the Engineering Change Control (ECC) must be approved prior to initiating anychanges to technical equipment.

Unplanned / Emergency Change Requestso Unplanned Change Requests (Emergency Change Request) include

technical equipment repairs that are needed in order to maintain and preserve safety, product quality or product integrity.

o Quality must approve the unplanned / emergency request prior to initiating any repairs to the Technical Equipment. Note: Quality authorization may be given verbally, but should then be documented on FRM2974.

o The requestor is to notify the department manager or designee of the Unplanned / Emergency Change request.

o The ECC then follows the same review and approval process as Planned Change Requests.

OFFICIAL COPY





7.3 Change Information (Section 1.2)The requestor is responsible for providing detailed explanation of the: Description of Change (What is being changed?)

o Changes related to existing Technical Equipment must include sufficient identification for traceability (i.e. Manufacturer, model, serial number, and asset or equipment ID number).

o A New Equipment Form, FRM2974 must be completed for all new equipment.

o New or upgraded software applications must include the name, version and manufacturer. Hardware changes must include the manufacturer / vendor and parts number.

Justification for Change (Why is this change being made?)o Examples of justification for change include, but are not limited to:

Process improvements, which impact the validated state of the manufacturing equipment.

Installation new equipment or modification of existing equipment. Facility or utility changes. Change requests which are customer driven. Changes in equipment operating parameters.

If the justification of change is related to a regulatory requirement, briefly state the regulatory event. Include a copy of the CAPA or any significant information related to the CAPA or other documentation.

7.4 Impact of Change (Section 2.1) Classify the change as a Minor or Major.

o Changes can be classified as major or minor depending on the nature and extent of the changes and the effects these changes may impact on the process.

Priority Description

MajorAn impact on the regulatory commitments, qualifications and/or validation status that could reasonably be expected to have substantial impact on the Safety, Identity, Strength, Quality, or Purity (SISPQ) of the product.

Minor

A change that is required but has no impact on the regulatory commitments, qualifications and/or validation status or has a minor potential impact on the SISPQof the product. The change has no impact on the validated state of the facility, utility, equipment, or instrument or automated computer system.

Determine if the change will have a direct or indirect product contact.

OFFICIAL COPY





7.5 Regulatory Impact (Section 2.2)If there is a Regulatory Impact of the ECC request, Regulatory Affairs will be responsible for determining if any regulatory submissions are required due to the change. The regulatory submission number will be documented if required.

7.6 Safety / Environmental Impact (Section 2.3)This section of the ECC report should be completed by Environmental Health and Safety (EHS). EHS is responsible for determining what safety activities need to be implemented prior to, during, or following the completion of the change. Any required actions should be documented in Section 2.9 of FRM2974.

7.7 Ancillary Systems (Section 2.4)Identify the ancillary systems that are impacted due to the proposed change. Changes to one area may have impacts in another area or department. Therefore, consideration should be given to the potential scope of the change. User Groups, Maintenance, and Engineering are key group that may assist in determining the impact of change on ancillary systems. Appropriate control actions should be documented in Section 2.9 of FRM2974 for any systems that are identified to be impacted by the change.

These include, but not limited to, systems such as:

Automated Process Controls, HVAC, Natural Gas, Nitrogen, Vacuum, Purified Water, Compressed Air, Heat Transfer Fluids, Electrical Systems, Solvents

7.8 Procedural / Documentation Impact (Section 2.5)Review SOPs or other documentation that may be affected by the proposed change. Common types of documentation that may be impacted are listed in Section 2.5 of FRM2974, however this is not a comprehensive list and will vary by project. Quality and Operations are key groups for determining the extent of documentation impact from an engineering change. Any new or revised documentation requirements are then listed in Section 2.9 of FRM2974 with associated timing for implementation.

7.9 Equipment/Manufacturing Impact (Section 2.6)Identify the impact to existing/new manufacturing systems due to the proposed change. Section 2.6 of FRM2974 was designed to ask common questions for the types of

OFFICIAL COPY





equipment/manufacturing impact commonly experienced during change. This list is not all inclusive and should be adapted to the specific project. Engineering and Maintenance are key resources for determining the impact of a change on existing systems.

7.10 Validation Impact (Section 2.7)Review the proposed change for impact on the validated state of the process, cleaning system, or associated equipment. Validation and Technical Services are key resources for determining the impact of a change on existing qualifications/validations. Validation requirements will be defined and appropriate action items listed in Section 2.9 of FRM2974.

7.11 Quality Impact (Section 2.8)Quality Assurance will review the proposed change for impact to product and to document agreement with the change classification. Quality will determine any equipment or product hold requirements. Quality will also determine if client notification is required by referencing the appropriate customer quality agreements. Typically, client notification is required for Major changes. Quality requirements will be defined and appropriate action items listed in Section 2.9 of FRM2974.

7.12 Change Implementation Requirements (Section 2.9)This section lists action items that are required in order to successfully complete this change. Impact Evaluation Items from Sections 2.2-2.8 of FRM2974 will generally have associated action items. Change control action items are a convenient tool for project managers in the development of project timelines. Examples of action items that may be documented are:

URS – User Requirements Specification DQ – Design Qualification FAT – Factory Acceptance Test SAT – Site Acceptance Test Work Orders associated with the change. Identify equipment modifications such as PLC / HMI upgrades Equipment maintenance and instrument calibrations required. Identification equipment instrument calibrations required due to equipment

changes. Technical equipment drawing updates. Completion of validation Turn Over Packages Receipt of technical data sheets. Equipment Specifications. Written proof that the client has approved the change request.

OFFICIAL COPY





Changes to Master Production Record which are impacted by technical changes.

Validation documents. Product/Equipment Hold tags.

There are three timing phases for change implementation:1. Pre-change requirements – The requirements identified in the Impact Evaluation

that must be completed before intervening with the area/equipment. Examples: Approve a contractor, request environmental permitting, prepare appropriate safety/GMP processes for the duration of the change.

2. Pre-release for use requirements – The requirements identified in the Impact Evaluation that must be completed before the approval of the equipment/area for production use. Examples: SOPs, Batch Records, Equipment qualification, Area inspections, Employee Training.

3. Closeout requirements – The requirements identified in the Impact Evaluation thatcan be completed after the approval of the change for routine use but must be completed before the change is officially closed in the system. For example, a system may be released to production for use during process validation activities.

7.13 Change Implementation Pre-Approval (Section 3.0)The ECC must be approved by Quality Assurance and Department Owner. The following table indicates suggested reviewers dependent on the type of change. The reviewer of the ECC signs in Section 3.0 of FRM2974.

Type of Change Eng

inee

ring

Man

ufac

turi

ng

EH

S

IT Reg

.Com

plia

nce

R&

D

Sup

ply

Cha

in

Tec

hnic

al S

ervi

ces

Ana

lyti

cal

Sci

ence

s

Val

idat

ion

Equipment X X X X X XFacilities X X X X X XUtilities X X X X XInstrument XLab Equipment X X XComputerized System X X

Quality Assurance shall determine the appropriate review requirements for change types not discussed in the above matrix.

OFFICIAL COPY





7.14 ECC Amendments (Sections 4.1-4.3)If the change proposal and/or requirements need to be revised or are not accomplished per the original proposal after the pre-approval of the change, an ECC Amendment is required. All amendments must be reviewed and approved prior to implementation by the Department Owner and Quality Assurance (at minimum).

The Requestor will provide a brief description of the amendment to the approved ECC. A separate attachment may be provided if additional information is required. Additional Implementation Requirements are documented in Section 3.3.

If no amendments are required, each section is marked as N/A.

7.15 Release for Use (Section 4.1)Quality Assurance Management may release the Technical Equipment for use in production prior to completion of all change requirements. For example, the equipment may be placed back into service while process validation activities are underway. The rationale for releasing the equipment back into service must be documented. For equipment to be released for use, all Pre-Release for Use Implementation Items (Sections 2.9 and 4.3 of FRM2974) should be completed. If there are outstanding items, additional rationale must be provided to document why release is acceptable.

If the equipment has been placed on Equipment Hold during the change process, the approval of the Release for Use section will authorize the removal of the Equipment Hold tag.

If it is not necessary to release the equipment prior to close-out of change control paperwork, then this section may be marked as N/A.

7.16 Change Close Out Review (Section 6.1)Once all change control requirements have been completed and approved, the change can be closed. A Quality representative will review the requirements listed in Section 6.1 to ensure that all implementation requirements have been completed and appropriate documentation is attached or referenced.

Once the review is complete, the change is marked as “Complete”. If the change was abandoned, Sections 7.1 and 7.2 of FRM2974 must be completed.

7.17 ECC Post Approval (Section 6.2)The Quality Assurance Management and Department Manager will review the completed change control documentation and approve the closing of the change control.

OFFICIAL COPY





7.18 ECC Cancellation (Section 7.1-7.2)To cancel an ECC, a rationale needs to be provided. A review of all activity associatedwith the ECC needs to be evaluated to determine if the activities impact the SISPQ of the technical equipment listed at pre-approval. To close the ECC, a signature approval from the Department Owner and Quality Assurance are required.

8. RelatedDocuments Regulations

o ICH Q7 Section XIII, Change Control (13)o ICH Q7 Section VI, Documentation and Records (6)o PIC – PH 1/96

Standard Operating Procedures (SOPs)o SOP69395: Document Change Control Systemo SOP69451: Electronic Data Disposalo SOP69535: Computer System Validation Requirements o SOP69536: Equipment, Instrument, Systems and Facilities Qualification

Procedureo SOP69394, Equipment, Receipt, Removal and Namingo SOP69450, Part 11 Complianceo SOP69449, Electronic Data Back-Upo FRM2974 Engineering Change Control Formo FRM3379 Decommissioning form

9. Change History.05 CMLR162

OFFICIAL COPY





Appendix1- Definitions

Change: A planed alteration, replacement, origination of a new item (e.g. product, facility) or elimination of specifications, methods, facilities, utilities, equipment, computer systems, master records or controls that are used for the manufacture, processing, packaging or holding of an API to ensure it meets all its safety, identity, strength, purity and quality (SISPQ) requirements.

Design Qualification (DQ): ICHQ7A defines DQ as the documented verification that the proposed design of facilities, systems, and equipment is suitable for the intended purpose.

Emergency Change (Unplanned Change): A change to a Technical Equipment whichneeds to be repaired immediately in order to maintain and preserve safety or product quality. The unplanned work is required for equipment, utility, or facility failure and may be implemented before approval of the Engineering Change Control.

Engineering Change Control (ECC): A system to evaluate, document, approve and implement changes and non-routine maintenance activities to equipment, utilities, facilities, instruments, and computerized systems to ensure they are maintain a safe and compliant state.

Equipment Hold: A process that is used to prevent Technical Equipment from being used for any manufacturing or R&D purposes prior to post-approval of the change.

Like-for-Like Change: Replacement of a component with another component with identical characteristics, functions and material of construction, but not necessarily the same manufacturer or model number.

Non-Routine: Any maintenance or work performed that is not detailed as preventative maintenance / calibration within the equipment or system standard operating procedure (SOP). This includes all changes, additions, replacements, and removal of equipment.

Owning Department: The department with ultimate responsibility for the technical equipment.

Planned Change: A change that is scheduled. Planned changes are made to reduce the risk of impact of the Safety, Identity, Strength, Purity and Quality of the product or the validated state of the Technical Equipment.

Product Hold – A process used to quarantine any product or material produced usingvalidated Technical Equipment when a change is implemented through the ECC / Validation process.

SISPQ: Acronym for Safety, Integrity, Strength, Purity and Quality. Technical Equipment: Facilities, utilities, manufacturing/packaging equipment,

instruments, computerized equipment, analytical equipment/ test requirements, which may impact the validated state or stability of the intermediate or final product APIs.

User Requirement Specifications (URS): Defines such items as the material of construction, utility operating parameters for the Technical Equipment. The URS can be used as a guide for planning cost, timetables, milestones, testing, etc. requirements,

OFFICIAL COPY





operating limits and / or software requirements of the Technical Equipment for stakeholders.

OFFICIAL COPY





Appendix2– ECCFlowChart

OFFICIAL COPY





Appendix 3: QC Exemptions

1. Gas Chromatogram (GC) – needle septa, liner, jet tip, gold seal, columns2. Liquid Chromatogram (LC) – inlet filter, frits, capillary tubing, and new column

change out3. Karl Fischer (KF) – diaphragm, desiccant, septa, solvent4. pH meter probe replacement5. ICP – torches tubing, spray chamber, nebulizer6. Auto-titrator – probe replacement for titrator and conductivity7. HPLC – flow cell and needle set8. Changes in reagents, solvents, and other items used in common operation of QC

equiment

OFFICIAL COPY

Signature Manifest

Document Number: SOP69408 Revision: 05

Title: Equipment, Facilities and Utilities Work Order and Change Control System

All dates and times are in Eastern Standard Time.

SOP69408

Author Approval

Name/Signature Title Date Meaning/Reason

Joseph Daujotas (JDAUJOTAS)

Kristin Shuler (KSHULER) Sr. Validation Engineer 21 Nov 2014, 12:32:54 PM Approved

Department Approval


John Zobel (JZOBEL)

Martin Meyer (MMEYER)

Ralph Varrato (VARRATOR)

Ron Frank (RFRANK) MANAGER 21 Nov 2014, 01:27:03 PM Approved

QA Approval


Michael Hermanek (MHERMANEK)

Associate Director, QA 05 Jan 2015, 02:10:06 PM Approved

Document Control Release


Kelly Shalifoe (KSHALIFOE)

Amy Rezachek (AREZACHEK)

Erika Hewitt (EHEWITT)

JeriAnn Olivo (JOLIVO) Document Control Specialist 12 Jan 2015, 03:21:08 PM Approved

SOP69408

Author Approval


Joseph Daujotas

OFFICIAL COPY

(JDAUJOTAS)

Kristin Shuler (KSHULER) Sr. Validation Engineer 22 Jan 2015, 08:14:10 AM Approved

Department Approval


Ron Frank (RFRANK) MANAGER 22 Jan 2015, 08:33:19 AM Approved

Martin Meyer (MMEYER) MANAGER 22 Jan 2015, 09:18:15 AM Approved

Ralph Varrato (VARRATOR) SR DIRECTOR 26 Jan 2015, 10:11:00 AM Approved

John Zobel (JZOBEL) DIRECTOR 26 Jan 2015, 10:40:14 AM Approved

QA Approval


Michael Hermanek (MHERMANEK)

Roy Candler (RCANDLER) Senior Manager 26 Jan 2015, 11:10:51 AM Approved

Document Control Release


Amy Rezachek (AREZACHEK)

Erika Hewitt (EHEWITT)

Kelly Shalifoe (KSHALIFOE)

JeriAnn Olivo (JOLIVO) Document Control Specialist 26 Jan 2015, 11:26:20 AM Approved

OFFICIAL COPY

Equipment, Facilities and Utilities Work Order and Change Control...

Documents

Transcript of Equipment, Facilities and Utilities Work Order and Change Control...