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