Procedure for Approving QC Results
| Department | Quality Control (QC)/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/088 |
| 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 a systematic approach for approving Quality Control (QC) test results in ointment manufacturing. This ensures that test results are accurate, meet Good Manufacturing Practices (GMP), and comply with product specifications before product release.
2. Scope
This SOP applies to all personnel in the Quality Control (QC) and Quality Assurance (QA) departments responsible for reviewing, verifying, and approving QC test results for raw materials, in-process samples, and finished products.
3. Responsibilities
- QC Analyst: Conducts quality control tests and records test results.
- QC Supervisor: Reviews test results and ensures they meet acceptance criteria.
- QA Officer: Cross-checks QC data for completeness and accuracy.
- QA Manager: Approves QC test results before batch release.
4. Accountability
The QA and QC Managers are accountable for ensuring that QC results are reviewed, approved, and documented as per GMP and regulatory requirements.
5. Procedure
5.1 QC Data Review Process
- Ensure that all QC test results are recorded in the QC Test Report.
- Verify that raw data, instrument logs, and calibration records are complete.
- Check that QC tests were performed according
to validated methods.
5.2 Verification of QC Test Results
5.2.1 Raw Material Testing
- Confirm that raw material test results meet predefined specifications.
- Ensure that raw material Certificate of Analysis (CoA) is reviewed and approved.
5.2.2 In-Process Testing
- Verify test results for pH, viscosity, and microbial contamination.
- Ensure that in-process test results meet process control parameters.
5.2.3 Finished Product Testing
- Check assay, microbial limits, and packaging integrity test results.
- Confirm that all test results meet final product specifications.
5.3 Handling Out-of-Specification (OOS) Results
- Identify test results that do not meet acceptance criteria.
- Initiate an OOS investigation following OOS procedures.
- Implement corrective and preventive actions (CAPA) if required.
5.4 Final Approval of QC Test Results
- Ensure all QC test results are reviewed by the QC Supervisor.
- QA Officer cross-verifies the QC data and signs off on test results.
- QA Manager provides final approval for batch release.
5.5 Documentation
- Record all approved QC test results in the QC Test Log.
- Ensure traceability of test reports for future audits.
- Store all test results securely for regulatory inspections.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- CoA – Certificate of Analysis
- OOS – Out of Specification
- CAPA – Corrective and Preventive Action
7. Documents
- QC Test Report (Annexure-1)
- QC Test Approval Log (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- USP <1225> – Validation of Compendial Procedures
- ICH Q6A – Specifications: Test Procedures and Acceptance Criteria
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: QC Test Report
| Date | Batch Number | Test Parameter | Result | Acceptance Criteria | Status | Reviewed By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | pH | 6.5 | 5.5 – 7.5 | Pass | QC Supervisor |
| 01/02/2025 | OINT-102 | Microbial Limits | Compliant | Absent | Pass | QC Supervisor |
Annexure-2: QC Test Approval Log
| Date | Batch Number | Test Type | Result | Final Approval Status | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Final Release Testing | Pass | Approved | QA Head |
| 02/02/2025 | OINT-102 | Final Release Testing | Pass | Approved | QA Head |
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 |