Standard Operating Procedure for Reporting Quality Control Results of Gel Products
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/070/2025 |
| Supersedes | SOP/GM/070/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 02/06/2025 |
| Effective Date | 04/06/2025 |
| Review Date | 02/06/2026 |
1. Purpose
To outline the standardized procedure for compiling, reviewing, and reporting quality control (QC) test results of gel formulations to ensure that all results are accurately recorded, approved, and communicated.
2. Scope
This SOP is applicable to all finished and semi-finished gel batches manufactured and tested
in the Quality Control department of the pharmaceutical facility.
3. Responsibilities
- QC Analyst: Perform testing and record raw data.
- QC Reviewer: Review raw data and calculations for accuracy.
- QA Officer: Verify final reports before release.
4. Accountability
The Quality Control Head is accountable for implementation and compliance of the procedure.
5. Procedure
5.1 Test Execution and Data Entry
- Perform QC tests as per approved specifications for the gel product.
- Record observations and readings immediately in raw data sheets or electronic systems.
- Ensure all entries are legible, dated, and signed.
5.2 Data Review
- Reviewer shall verify raw data for completeness and accuracy.
- Recheck calculations and units for correctness.
- Verify that the results meet specifications.
5.3 Report Compilation
- Transfer approved data to the Final QC Report format (Annexure-1).
- Attach test protocols, chromatograms, and calculations where applicable.
- Obtain signatures from the Analyst and Reviewer.
5.4 Communication of Results
- Submit final QC report to QA for verification.
- Share test report with Production and Warehouse if batch clearance is required.
- In case of Out of Specification (OOS) results, follow SOP for OOS handling.
5.5 Report Storage and Archival
- Maintain soft and hard copies of reports for a minimum of 5 years.
- Store in locked and humidity-controlled archive room.
6. Abbreviations
- QC: Quality Control
- QA: Quality Assurance
- OOS: Out of Specification
- SOP: Standard Operating Procedure
7. Documents
- Final QC Report Format – Annexure-1
- Raw Data Recording Sheet – Annexure-2
8. References
- ICH Q6A: Specifications – Test Procedures and Acceptance Criteria
- 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Final QC Report Format
| Product Name | |||
|---|---|---|---|
| Batch No. | |||
| Test Performed | Result | Specification | Status (Pass/Fail) |
| Appearance | |||
| pH | |||
| Viscosity | |||
| Assay | |||
| Microbial Test | |||
| Preservative Efficacy |
Annexure-2: Raw Data Recording Sheet
| Test Name | Observed Value | Date | Analyst Signature |
|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 20/06/2022 | 1.0 | Initial version | New SOP | QA Head |
| 02/06/2025 | 2.0 | Added detailed annexure formats | Compliance Update | QA Head |