Procedure for Maintaining QA Approval Logs
| Department | Quality Assurance (QA)/Quality Control (QC)/Production |
|---|---|
| SOP No. | SOP/Ointment/158 |
| 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 maintaining Quality Assurance (QA) approval logs in pharmaceutical manufacturing. These logs provide traceability and ensure regulatory compliance for batch approvals, document verifications, deviation authorizations, and other QA-related activities.
2. Scope
This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), and Production departments responsible for recording, reviewing, and maintaining QA approval logs for manufacturing, validation, deviation approvals, and batch releases.
3. Responsibilities
- QA Officer: Updates QA approval logs with relevant details.
- QC Analyst: Provides verification data to support QA approvals.
- Production Supervisor: Ensures batch documents are submitted for QA approval.
- QA Manager: Reviews and approves QA logs for compliance.
4. Accountability
The QA Manager is accountable for ensuring that all QA approval logs are maintained in compliance with GMP, FDA, ICH, and WHO regulations.
5. Procedure
5.1 Types of QA Approval Logs
The following types of QA approval logs must be maintained:
- Batch Manufacturing Record (BMR) Approval Log: Documents approvals for batch processing.
- Deviation and CAPA Approval Log: Records QA approvals for deviations
and corrective actions.
Validation Approval Log: Maintains records of validation study approvals.
Change Control Approval Log: Documents QA approvals for process or document changes.
Vendor and Material Approval Log: Tracks approval of raw materials and vendor qualifications.
5.2 Recording QA Approvals
- QA approvals must be recorded in **real-time** to ensure traceability.
- The following details must be recorded for each approval:
- Approval date and time.
- Document reference number (Batch No., Deviation No., Validation No.).
- Nature of approval (batch release, deviation clearance, validation sign-off).
- QA Officer’s name and signature.
- QA Manager’s authorization.
- Electronic logs must be maintained in a **validated document control system** with controlled access.
5.3 Review and Verification of QA Approval Logs
- QA must review approval logs **weekly** for completeness.
- Any discrepancies in approval logs must be investigated and corrected.
- QA logs must be **cross-verified with batch records, deviation reports, and validation documents**.
5.4 Archiving and Retention of QA Logs
- All QA logs must be archived in a **secure, fire-resistant storage area**.
- Retention period for QA logs:
- Batch approvals – **Minimum 5 years**.
- Deviation approvals – **Minimum 3 years**.
- Validation approvals – **Minimum 5 years**.
- Archived QA logs must be **retrievable for regulatory audits**.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
- CAPA – Corrective and Preventive Action
- FDA – Food and Drug Administration
- ICH – International Council for Harmonisation
7. Documents
- QA Approval Log Template (Annexure-1)
- QA Review Checklist (Annexure-2)
8. References
- ICH Q10 – Pharmaceutical Quality System
- WHO Guidelines on QA Documentation
- US FDA Guidance on QA Oversight
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: QA Approval Log Template
| Date | Document Reference | Approval Type | QA Officer | QA Manager |
|---|---|---|---|---|
| 02/02/2025 | BMR-1001 | Batch Release | John Doe | Approved |
Annexure-2: QA Review Checklist
| Approval Log Type | Verification Date | Reviewed By | Findings | Corrective Actions |
|---|---|---|---|---|
| Deviation Approval | 03/02/2025 | Jane Smith | Incomplete Entry | QA Update Required |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Procedure | Improved QA Documentation | QA Head |