Procedure for QA Documentation Practices
| Department | Quality Assurance (QA)/Quality Control (QC)/Production |
|---|---|
| SOP No. | SOP/Ointment/090 |
| 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 define the documentation practices required for Quality Assurance (QA) activities in ointment manufacturing. Proper documentation ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and product quality standards.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Quality Control (QC), and Production departments responsible for preparing, reviewing, maintaining, and archiving documentation related to manufacturing, testing, and quality control.
3. Responsibilities
- QA Officer: Ensures accurate and complete documentation of QA activities.
- QC Analyst: Records analytical and test results as per defined procedures.
- Production Supervisor: Ensures documentation of batch manufacturing records (BMR) and process deviations.
- QA Manager: Reviews and approves all QA documentation before final archiving.
4. Accountability
The QA and QC Managers are accountable for ensuring that all documentation is maintained as per GMP and regulatory requirements.
5. Procedure
5.1 General Documentation Requirements
- All documents must be prepared, reviewed, and approved as per defined formats.
- Handwritten entries must be clear, legible, and in permanent ink.
- Corrections must be made using a single-line strike-through, followed by initials and date.
- No overwriting or erasing of data is allowed.
5.2 Types of QA Documents
5.2.1 Batch Manufacturing Records (BMR)
- Must contain complete details of batch processing.
- Each entry must be signed and dated by responsible personnel.
- Reviewed and approved by QA before batch release.
5.2.2 Standard Operating Procedures (SOPs)
- All procedures must be documented and followed as per the approved SOPs.
- Each SOP must have a unique SOP number, version control, and approval signature.
- Any revision in SOPs must be documented with justification.
5.2.3 Quality Control Test Records
- All test results must be recorded with supporting raw data.
- Test results must meet predefined acceptance criteria.
- All analytical test results must be verified and approved by QA.
5.2.4 Deviation and Change Control Records
- All deviations must be recorded, investigated, and approved.
- Any changes in manufacturing processes must follow change control procedures.
5.2.5 Logbooks
- Equipment usage and cleaning logbooks must be maintained.
- Personnel entry and exit records must be updated regularly.
5.3 Review and Approval Process
- QA must review all completed records before batch release.
- QC must verify all analytical data before submission to QA.
- QA Manager must approve all critical documents before finalization.
5.4 Document Storage and Retention
- All documents must be stored in a designated QA archive.
- Retention periods for different documents must follow regulatory guidelines.
- Records must be easily retrievable for audits and regulatory inspections.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
- SOP – Standard Operating Procedure
7. Documents
- QA Documentation Checklist (Annexure-1)
- QA Document Review Log (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q7 – Good Manufacturing Practice Guide
- ICH Q10 – Pharmaceutical Quality System
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 Documentation Checklist
| Document Type | Requirement | Compliant (Yes/No) | Remarks |
|---|---|---|---|
| BMR | All fields completed | Yes | Compliant |
| SOPs | Latest version available | Yes | Compliant |
| QC Test Records | Results reviewed by QA | No | Pending review |
Annexure-2: QA Document Review Log
| Date | Document Type | Reviewed By | Findings | Approval Status |
|---|---|---|---|---|
| 01/02/2025 | BMR – OINT-101 | QA Officer | Complete | Approved |
| 02/02/2025 | SOP Revision | QA Manager | Needs update | Pending |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |