Standard Operating Procedure for Reporting QC Out-of-Specification (OOS) Results in Elixir Testing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/238/2025 |
| Supersedes | SOP/ELX/238/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To outline the procedure for identifying, documenting, investigating, and reporting Out-of-Specification (OOS) test results observed during the Quality Control analysis of elixir products, in compliance with cGMP and regulatory standards.
2. Scope
This SOP applies to all Quality Control (QC) testing activities including raw materials, in-process, finished product, and stability samples related to elixir formulations at any testing stage.
3. Responsibilities
- QC Analyst:
- Immediately notify any observed OOS result and document data accurately.
- QC Supervisor:
- Review test data and initiate a Phase I laboratory investigation.
- QA Officer:
- Initiate Phase II investigation if required and ensure regulatory compliance of the OOS report.
4. Accountability
The Head of QC is accountable for ensuring timely and complete reporting of OOS events. The Head of QA is responsible for ensuring proper documentation and final disposition of affected materials.
5. Procedure
5.1 Identification of OOS
- An OOS result is any test result that falls outside the approved specification range or trend limits.
- The analyst must immediately:
- Stop further testing on the batch
- Notify the QC Supervisor
- Record the result and conditions in the raw data sheet
5.2 Phase I: Laboratory Investigation
- QC Supervisor reviews the method, calculations, standards, reagents, and instrument conditions.
- Determine if the result is due to:
- Analytical error
- Instrument malfunction
- Improper sample preparation
- Repeat the test only with QA approval if lab error is confirmed.
5.3 Phase II: Full-Scale Investigation
- If no lab error is confirmed, QA initiates a Phase II investigation.
- Evaluate:
- Manufacturing deviations
- Equipment logs and calibration history
- Batch manufacturing record (BMR)
- Prepare a formal OOS Investigation Report with CAPA (Corrective and Preventive Actions).
5.4 Decision and Disposition
- QA, in consultation with QA/QC and Production, makes a decision on the product status:
- Release (if valid retest justifies original result)
- Reject (if result confirmed)
- Rework (if permitted)
- Update the Product Quality Review (PQR) with any confirmed OOS.
5.5 Documentation
- Maintain all data in the OOS Register (Annexure-1).
- Attach raw data, investigation checklist, and CAPA form.
- Final report must be signed by QA Head before closure.
6. Abbreviations
- SOP: Standard Operating Procedure
- OOS: Out-of-Specification
- CAPA: Corrective and Preventive Action
- QC: Quality Control
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
7. Documents
- OOS Register (Annexure-1)
- OOS Investigation Form
- CAPA Form
8. References
- 21 CFR Part 211.192 – Production Record Review
- MHRA OOS Guidelines
- WHO Technical Report Series No. 996, Annex 2
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: OOS Register
| Date | Batch No. | Test Parameter | OOS Value | Specification | Disposition | QA Review |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-0425-054 | Assay | 88.2% | 90.0% – 110.0% | Rejected | Sunita Reddy |
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 | Updated with phase-wise investigation process | GMP Enhancement | QA Head |