Procedure for Documentation of QC Test Results
| Department | Quality Control (QC)/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/070 |
| 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 documenting Quality Control (QC) test results to ensure data integrity, regulatory compliance, and traceability in pharmaceutical manufacturing.
2. Scope
This SOP applies to all personnel in the Quality Control (QC) and Quality Assurance (QA) departments responsible for recording, reviewing, and maintaining QC test data for raw materials, in-process materials, and finished pharmaceutical products.
3. Responsibilities
- Quality Control Analyst: Conducts QC tests and documents results in relevant records.
- Quality Assurance Personnel: Reviews and approves test documentation for accuracy and compliance.
- QC Supervisor: Ensures that all test results are recorded and reviewed as per company and regulatory requirements.
- Data Integrity Officer (if applicable): Ensures compliance with ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete) principles.
4. Accountability
The QC and QA Managers are accountable for ensuring that all QC test results are documented accurately and securely maintained as per regulatory requirements.
5. Procedure
5.1 General Documentation Requirements
- All QC test results must be recorded in a designated QC test logbook, worksheet, or electronic system.
- Data entries must be in real-time, without backdating or postdating.
- Corrections should be made with a single line strike-through, initialed, and dated.
- All results must be reviewed and signed by a second QC personnel or supervisor.
- Ensure proper documentation format, including:
- Test Date and Time
- Analyst Name and Signature
- Test Method Reference
- Equipment ID and Calibration Status
- Test Results (Numerical and Observational)
- Final Status (Pass/Fail)
5.2 Documentation of Specific QC Tests
5.2.1 Raw Material QC Tests
- Record results for each raw material batch, including assay, moisture content, and microbial limits.
- Compare results against approved raw material specifications.
5.2.2 In-Process QC Tests
- Document test results at defined stages of manufacturing.
- Record parameters such as pH, viscosity, particle size, and microbial counts.
5.2.3 Finished Product QC Tests
- Record physical, chemical, and microbiological test results.
- Ensure all acceptance criteria are met before product release.
5.3 Electronic Documentation (If Applicable)
- QC results recorded in an electronic system must have user authentication.
- Audit trails must be enabled to track data modifications.
- Electronic signatures must comply with 21 CFR Part 11 requirements.
5.4 Archiving and Retention of Records
- Hard copy records must be stored in secured filing cabinets.
- Electronic records should be backed up as per company data policies.
- Retention periods must comply with GMP regulations (typically 5 – 10 years).
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- ALCOA+ – Attributable, Legible, Contemporaneous, Original, Accurate, and Complete
7. Documents
- QC Test Log (Annexure-1)
- Final Product QC Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 11 – Electronic Records and Signatures
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
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 Log
| Date | Batch Number | Test Parameter | Test Result | Equipment ID | Final Status | Verified By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | pH | 6.2 | PH-200 | Pass | QA Officer |
| 02/02/2025 | OINT-102 | Viscosity | 45,000 cP | VIS-300 | Pass | QA Officer |
Annexure-2: Final Product QC Report
| Date | Batch Number | Test Method | Acceptance Criteria | Result | Final Status | Approved By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | HPLC Assay | 95% – 105% | 98.5% | Approved | QA Head |
| 02/02/2025 | OINT-102 | Microbial Testing | Within limits | 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 |