Department | Quality Management | Document no | QMS-180 | ||
Title: Quality Assurance Change Control Procedure | |||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
1. Purpose
The purpose of this Standard Operating Procedure is to describe the process that must be followed when implementing a change that will impact the product or any process within the quality management system.
2. Scope and Application
This procedure applies to any change that may affect:
– Starting material
– Product component
– Process Equipment
– Process environment (or site)
– Method of production or testing
– Computer software
– Product data/integrity
– Any other change that may affect product quality or reproducibility of the process.
This procedure does not apply to:
– The manufacture of experimental batches for process development
– Unplanned deviations
– Batch Rework
– Documentation changes
– Printed Packaging
The Change control procedure will ensure that there is sufficient data to support the change and that the change will result in a product of the desired quality, consistent with the approved specifications. The impact on facilities, systems and equipment will be evaluated. The risk assessment will determine the need for validation or qualification of equipment.
3. Safety and Process Specific Information
All safety requirements for relevant areas at any GMP facility must be followed at all times.
4. Environmental Health and Safety
The impact on Environmental Health and Safety must be considered when implementing any change control.
5. Reference Documents
1. Quality Risk Management Techniques (QMS-135)
2. Risk Assessment Register (Form 930)
3. Change Control Tracking Form (Form 920)
4. Change Review Form – Toll Customer (Form 925)
6. Responsibility
1. Change champion:
– Raise change control.
– Collect background information to support the change.
– Complete risk assessment with the assistance of a QA Associate (if required)
– Assign tasks with the assistance of a QA Associate (if required)
– Ensuring that changes are completed within the agreed time.
– Investigate and report reasons for delay.
– Attending review meetings coordinated by the QA Associate.
2. QA Associate:
– Assign a unique change control number.
– Maintain change control database.
– Ensure that all documentation is complete.
– Ensure that sufficient information has been provided to support the change.
– Chairing change control meetings
– Closure of changes after review of submitted implementation evidence.
3. QA Manager:
– Confirm that the impact of the change has been appropriately assessed and the proposed actions are adequate in evaluating the impact.
– Provide ultimate approval or cancellation of a change in case of dispute.
7. Definitions
1. Change Control – a documented system of managing and evaluating proposed changes that may impact product, production or process.
2. Change Proposal – A formal, documented process by which selected representatives evaluate and either approve or disapprove proposed product/process changes.
3. Change Summary – is the collective documentation associated with the change, which supports that all steps have been completed as per the proposal.
4. Change control champion – the individual proposing and managing the change.
5. Change control Panel – Subject matter experts who will review the change for impact on their respective areas of expertise.
6. Implementation Plan – The plan for implementing a change. The implementation plan must contain:
– Impact assessment – who / what / why
– Specific actions and person responsible for implementing change.
– Target completion date for change
– Critical control parameters pre- and post-implementation
– Identification of the first batch after implementation (if applicable)
7. Impact Assessment – A comprehensive review of the impact of the change. Section two of the change control form guides the impact assessment. The risk assessment should complement the impact assessments.
8. Major change – a change that potentially affects a product:
– Purity, Identity, Safety or Efficacy during any validated manufacturing process step.
– Change in a facility that supports the manufacturing process of registered product.
– Change in manufacturing equipment or process-validated state.
– Variation in product formulation.
– Change in conditions of registration as notified by regulatory body or contractor.
– Change in approved shelf life.
– Change in validated testing method or contractor.
– New Product Introduction – completed at the contractor or at a GMP facility.
– Changes in label conditions.
9. Minor change – any change that does not fit the major definition.
Refer to the flow chart below.
8. Procedure:
Note:
– Change Controls are only to be raised when all required information to approve changes is available. Discussions, information gathering, and planning are to occur outside of the change control.
– It is crucial that enough information is submitted to support the change, and the quantity will depend on the change’s perceived impact.
– Change control is not to be used as a planning tool.
Section 1 – Initiation Phase
8.1. The Change Champion refers to checklists that are stored in the change control Guidance document. These are intended as a guideline for tasks that may be required for a particular type of change. i.e. Raw Material / Equipment Changes, supporting data including bench scale or validation trials, testing and or stability results, etc.),
8.2. To initiate a change, the Change Champion will contact the Quality Assurance Associate and discuss the proposed change.
8.3. The Change Champion and the Quality Assurance Associate will jointly develop the required background information package to support the change. The Change Champion gathers background information from relevant parties to form the change package. Relevant information may include:
– Assessment of third-party notification (Toll customer review form, Form 925)
– Agree on Change Panel Members (See page 8)
– Justification for the change
– List of impacted products (if registered) and relevant market information
– Risk Assessment
– Implementation Strategy
– Supporting evidence for the change
8.4. The Change Champion, under the guidance of a Quality Assurance Associate, must complete the Change Control Tracking Form (Form 920) and a risk assessment of the change as per Quality Risk Management Techniques (QMS-135). This will determine the change impact category (major or minor).
Each change should have a unique number and a succinct title that outlines the nature of the change. The change control number will be in the format of CCYYYY-XXX (e.g. CC2021-037). Where CC reflects change control, YYYY denotes the calendar year, such as 2021, and XXX indicates the change control sequentially issued in that calendar year (e.g. 037 represents the 37th change in that calendar year).
8.5. The Quality Assurance Manager will review and, where appropriate, approve the risk assessment.
8.6. The Change Champion submits the change proposal package to the Quality Assurance Associate for completeness against the agreed background package.
8.7. If the background information presented is deemed acceptable by the Quality Assurance Associate, a folder will be created starting with the Change Control Tracking Form (Form 920), and a PDF copy of the change proposal will be saved. If further information is required, The Quality Assurance Associate will discuss it with the Change Champion. The folder will eventually be used to collect supporting information on the change in progress.
Section 2 – Change Control Package Review
8.8. A formal meeting will be chaired by the Quality Assurance Associate for the change control panel to discuss the change and agree on implementation tasks (including those identified in the risk assessment).
8.9. At the meeting, all change control panel members will sign and date the change control panel review page (if all agree) of the change control.
8.10. For each implementation task, the relevant department designee will nominate the staff member responsible for completing the task and the date by which it will be completed.
8.11. No changes are to be made to the agreed implementation plan unless approved by the QA Manager (or delegate.)
8.12. If any member of the change control panel does not approve the change, a meeting with the QA Manager (or delegate) and the Change Champion is held to resolve the issues.
Section 3 – Implementation
8.13. Upon approval of the change Control Package. The QA Associate will:
– Enter Implementation tasks into the database (including dates and persons responsible).
– Notify all staff of their delegated tasks.
– Update the Change Control folder with signed documentation.
Section 4 – Review and Closure
8.14. The change champion will supply evidence of closure of all implementation tasks (agreed to in section 3 by the change panel) to the Quality Assurance Associate.
Evidence of completion of the proposal may include updated SOP, training records of relevant staff in updated SOP, photographs, test results to support change, stability data (real-time / accelerated or both), validation data, inventory printouts, etc.
8.15. The Quality Assurance Associate reviews the closure evidence.
8.16. If extra information is required, the Quality Assurance Associate will liaise with the Change Champion to ensure all evidence of closure is provided.
8.17. The Quality Assurance Associate will review the complete package and approve the closure.
8.18. Upon approval, the Quality Assurance Associate will:
– Record the first batch where the change occurred (if applicable)
– Update change control database.
– PDF all documentation supporting the change (change package, worksheets, approvals, change summary) into the change control folder.
– Notify the change control panel and change champion.
9. Cancelling Changes
9.0. If the “Change is NOT approved” by QA, then the first page of the Change Control Tracking Form (Form 920) shall be crossed out and “CANCELLED” written on it. A short explanation should be given for why the change was not approved. The Quality Assurance Associate shall update the database and archive hard and soft copy documentation.
9.1. Where the cancellation of a change control affects a third party, they are notified by the Quality Assurance Associate. A copy of the correspondence is maintained.
10. Monitoring and Review of Changes
10.0. The Quality Assurance Associate will conduct weekly reviews of open change controls. A meeting will be held with Change Champions regarding progress. Change controls to be managed through these meetings will be selected based on:
– Business Priority
– Closure date
– Roadblocks
10.1. The Site Quality team will review the progress of closed and open changes monthly if necessary resources or action plans may be instigated to facilitate change implementation.
APPENDIX 1: Suggested participants of the Change Control Panel.
Approval Change Type | Engineering Manager | Formulation Manager | IT Manager | Logistics Manager | Process & Development | Production Manager | QA Disposition | QA Manager | QC Manager | Regulatory | Validation Manager | Safety Representative |
Raw Material (specification, source, storage, testing) | Y | Y | Y | Y | Y | Y | Opt | Opt | ||||
Testing (test method, expiry, specification, reagents) | Y (2) | Y (1) | Y | Y | Y | |||||||
Manufacturing Process (sterilisation, filtration, batch sizes, cleaning) | Y | Y (2) | Y (1) | Y | Y | Y | Y | Y | ||||
Equipment (alterations, replacement, construction, control units) | Y | Y | Y | Y | Y | |||||||
Methods (3) (changes) | OPT (4) | Y (4) | Y (4) | Y (4) | Y (4) | Y (4) | Y (4) | Y | Opt | |||
IT (Hardware, Software, LAN, automated systems, Plant software) | Y (5) | Opt | Y (5) | Y |
Appendix II. (1) Biological or immunological reagent change approval
(2) Pharmaceutical change approval
(3) Major Facility or equipment modifications approval
(4) Approval of SOP in area of expertise
(5) Relative to impact on department
NB: The above is a guide only. The Quality Manager can decide that an individual is not required to approve a change proposal based on content and can also add additional persons to the approval list as required.
In the absence of the nominated approver, authorized delegates can approve on their behalf as long as relevant expertise has been attained in that area.
APPENDIX 2: Change Control Tracking form (Form 920)
Section 1 – Initiation Phase
1. Change Details
Change Title: | |||
Change Control Champion | Department | ||
Date Initiated | DD / MMM / YYYY | Completion Required | DD / MMM / YYYY |
Product Description and Item Code (if applicable) | |||
Site Affected by Change | |||
Department/s Affected by Change | |||
Regulatory Change | Enter appropriate Agency names. | ||
Details completed by | Champion (initial/date) | DD / MMM / YYYY | |
Comments |
Detailing of Change / Justification and strategy
Current Situation | |
Proposed Situation | |
Change Justification | |
2. Products Impacted By Change
Product Name / Description | Product Item Code | Market impacted | Registered |
YES / NO | |||
YES / NO | |||
YES / NO | |||
YES / NO | |||
YES / NO | |||
YES / NO |
3. Risk Assessment – as per company Risk Assessment Procedure (refer to PQA-SOP-167 document series)
Outcome of Change Control Risk Assessment | Major / Minor | Champion (initial/date) | DD / MMM / YYYY | |
Attach risk assessment to change control | Champion (initial/date) | DD / MMM / YYYY | ||
Comments | If any list below | |||
Section 2 – Change Control Package Review
All Changes | Departments Required as Defined by Change Implications | |||||||
Department | Sign | Department | Sign | Department | Sign | |||
Quality | ☐ | Commercial | ☐ | Finance | ☐ | |||
Formulation | ☐ | Information Technology | ☐ | |||||
Logistics | ☐ | Maintenance | ☐ | |||||
Process Development | ☐ | Production | ☐ | |||||
Purchasing | ☐ | Quality Control | ☐ | |||||
Regulatory | ☐ | Safety | ☐ | |||||
Validation | ☐ | Warehouse | ☐ | |||||
Section 3 – Implementation
Implementation Strategy | Reference Number (QA Use Only) | Due Date | Responsible |
|
Section 4 – Review and Closure
1. Information Provided for change closure
List the first batch where change will occur |
Quality Assurance Associate reviews package and all evidence provided as per plan | YES / NO | Sign & Date | |
Comments | If more detail is required to close the change control progression, then state it in the comments field. | ||
Quality Assurance Associate closes change control in the database | YES / NO | Sign & Date | |
Quality Assurance Associate distributes closure notice to the Site review team | YES / NO | Sign & Date | |
Change Control file marked as closed and archived appropriately | YES / NO | Sign & Date | |
Comments | Include the list below; otherwise, mark it as Not Applicable. | ||
APPENDIX 3: Change Review Form – Toll Customer (Form 925)
Change Control Number: |
Reviewer: Toll Customer | ||
(Reviews for compliance to the reviewer are of expertise) | ||
☐ | Concur with requirements attached in Change information form and/or supporting memo. | |
☐ | Concur with requirements attached in Change information form and/or supporting memo plus the following additional requirements: | |
ADDITIONAL REQUIREMENTS (List only the additional requirements to aid requirement transcription. Requirement rationale should be included in the next section.)
Additional Before Implementation Requirements: | |
Additional Post-Implementation of the Change Requirements: | |
Additional Post-Release Requirements: |
RATIONALE FOR ADDITIONAL REQUIREMENTS / COMMENTS
Rationale for Additional Requirements: |
Additional Comments: |
SIGNATURE (Reviews for compliance to the reviewer are of expertise)
Approved By __________________ | Sign and Date |