Standard Operating Procedure for Verification of Test Results in Elixir Quality Control
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/237/2025 |
| Supersedes | SOP/ELX/237/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the procedure for the systematic verification of test results obtained during the quality control testing of elixir formulations to ensure data accuracy, reliability, and regulatory compliance.
2. Scope
This SOP applies to all raw data, calculations, instrument printouts, and final reports generated by the QC Department during in-process, finished product, and stability testing of elixirs.
3. Responsibilities
- QC Analyst:
- Record raw data legibly and accurately, ensuring calculations are complete and traceable.
- QC Reviewer/Supervisor:
- Verify calculations, instrument results, and compliance with specifications.
- QA Officer:
- Perform final verification prior to release of data and ensure traceability in audit trails.
4. Accountability
The QC Head is accountable for implementation and adherence to this SOP. The QA Head is responsible for ensuring integrity and regulatory acceptance of verified data.
5. Procedure
5.1 Data Entry by Analyst
- All results must be entered in black ink without overwriting or use of correction fluid.
- Any correction shall be signed, dated, and the reason mentioned.
- Results must be entered in predefined formats or test datasheets.
- Ensure calculations are done using approved methods and formulas.
5.2 Initial Review by Supervisor
- Verify:
- Sample ID and batch number consistency
- Instrument calibration status
- Use of correct analytical method and version
- Units, decimal accuracy, and limit compliance
- Cross-check all manual calculations or those from spreadsheets.
- Review chromatograms, spectrums, or graphs for anomalies or integration errors.
5.3 Second-Level QA Verification
- Confirm that:
- All results fall within approved specifications
- No test has been repeated without justification
- Out-of-trend or OOS results are properly documented and investigated
- Analyst and reviewer signatures are present on all pages
- QA to stamp and sign the final report for approval and archival.
5.4 Handling of Errors or Deviations
- If discrepancies are identified:
- Document under test discrepancy record
- Initiate a deviation or OOS as per applicable SOP
- Perform root cause analysis if necessary
- Re-testing shall be permitted only after QA approval and documented justification.
5.5 Final Report Compilation
- Ensure all raw data, printouts, calibration records, and calculations are compiled chronologically.
- Label each page with sample ID, batch number, and analyst initials.
- Final report shall be approved and archived in the product data file (PDF).
6. Abbreviations
- SOP: Standard Operating Procedure
- QC: Quality Control
- QA: Quality Assurance
- OOS: Out of Specification
- PDF: Product Data File
7. Documents
- Test Result Verification Logbook (Annexure-1)
- Batch Manufacturing Record (BMR)
- Test Datasheets and Raw Data Sheets
8. References
- 21 CFR Part 211.194 – Laboratory Records
- WHO TRS 986 Annex 2 – Good Practices for QC Laboratories
- ICH Q7 – Good Manufacturing Practice Guide
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Test Result Verification Logbook
| Date | Batch No. | Test Parameter | Analyst | Verified By | Comments/Corrections |
|---|---|---|---|---|---|
| 11/04/2025 | ELX-0425-053 | Assay | Rajesh Kumar | Sunita Reddy | None |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP Creation | QA Head |
| 11/04/2025 | 2.0 | Included second-level QA verification process | GMP Compliance Update | QA Head |