Procedure for Managing Change Control Records
| Department | Quality Assurance (QA)/Quality Control (QC)/Production/Regulatory Affairs |
|---|---|
| SOP No. | SOP/Ointment/164 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for managing change control records in pharmaceutical manufacturing. Change control ensures that all proposed changes to processes, equipment, documents, and materials are evaluated, approved, and documented before implementation to maintain compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
2. Scope
This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), Production, and Regulatory Affairs departments responsible for initiating, reviewing, approving, and maintaining change control records.
3. Responsibilities
- Change Requestor: Initiates a change control request and provides justification.
- QA Officer: Reviews change requests for impact assessment.
- QC Analyst: Evaluates potential effects on product quality.
- Regulatory Affairs Officer: Assesses regulatory implications.
- Change Control Committee (CCC): Approves or rejects change requests.
- QA Manager: Ensures proper documentation and implementation.
4. Accountability
The QA Manager and Change Control Committee (CCC) are accountable for ensuring that all change control records comply with GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Types of Changes Requiring Change Control
Change control is required for:
- Process Changes: Modifications in manufacturing, testing, or cleaning processes.
- Equipment Changes: Installation, replacement, or modification of machinery.
- Material Changes: Changes in raw materials, suppliers, or packaging components.
- Document Changes: Revisions to SOPs, batch records, and validation documents.
- Facility Changes: Modifications in manufacturing or laboratory areas.
- Regulatory Changes: Updates due to new compliance requirements.
5.2 Initiating a Change Control Request
- A Change Control Request (CCR) must be initiated using the **Change Control Request Form (Annexure-1).**
- The requestor must provide:
- Reason for change.
- Impact on product quality, process, or regulatory compliance.
- Proposed implementation timeline.
- The form must be submitted to **QA for preliminary review.**
5.3 Risk and Impact Assessment
- QA must conduct a **Risk and Impact Assessment** to evaluate:
- Potential impact on product safety and efficacy.
- Need for revalidation or additional testing.
- Effect on regulatory filings and approvals.
- QC must assess potential effects on raw materials, in-process controls, and finished product specifications.
- The assessment must be documented in the **Change Control Evaluation Report.**
5.4 Approval Process
- The **Change Control Committee (CCC)** must review the request and risk assessment.
- Approval categories:
- Approved: Change can be implemented with conditions.
- Approved with Modifications: Implementation requires further review.
- Rejected: Change poses unacceptable risk.
- Final approval must be provided by the **QA Manager.**
5.5 Implementation of Change
- Once approved, the change must be implemented as per the **Change Implementation Plan.**
- Training sessions must be conducted if procedural changes are involved.
- All implementation actions must be recorded in the **Change Implementation Log (Annexure-2).**
5.6 Verification and Effectiveness Check
- QA must conduct a **post-implementation review** within **30 days** to verify effectiveness.
- Key verification steps:
- Review of manufacturing and laboratory records.
- Evaluation of process performance.
- Regulatory compliance check.
- If issues arise, further corrective actions must be taken.
5.7 Archiving and Retention of Change Control Records
- All change control records must be archived in the **Change Control Master File.**
- Retention periods:
- Major changes – **Minimum 10 years.**
- Minor changes – **Minimum 5 years.**
- Records must be available for audits and regulatory inspections.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- CCC – Change Control Committee
- CCR – Change Control Request
- FDA – Food and Drug Administration
- ICH – International Council for Harmonisation
7. Documents
- Change Control Request Form (Annexure-1)
- Change Implementation Log (Annexure-2)
8. References
- ICH Q10 – Pharmaceutical Quality System
- WHO Guidelines on Change Management
- US FDA Guidance on Change Control
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Change Control Request Form
| Change No. | Description | Initiator | Date | QA Approval |
|---|---|---|---|---|
| CC-001 | Change in raw material supplier | John Doe | 02/02/2025 | Approved |
Annexure-2: Change Implementation Log
| Change No. | Implementation Date | Verification Date | Verified By | Final Status |
|---|---|---|---|---|
| CC-001 | 10/02/2025 | 15/03/2025 | QA Officer | Effective |