Standard Operating Procedure for Sample Disposal After Analysis in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/139/2025 |
| Supersedes | SOP/API/139/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define a systematic procedure for the safe, traceable, and environmentally compliant disposal of test samples after completion of Quality Control analysis in the API manufacturing facility.
2. Scope
This SOP applies to all raw material, intermediate, in-process, finished product, stability, and retained samples analyzed in the Quality Control Laboratory, excluding controlled samples.
3. Responsibilities
- QC Analyst: Identify
samples due for disposal and segregate accordingly.
QC Supervisor: Review sample status, verify documentation, and authorize disposal.
QA Officer: Ensure compliance with documentation, environmental safety, and regulatory guidelines.
4. Accountability
The Head – QC is accountable for enforcing proper disposal of all analyzed samples to prevent misuse and ensure safety.
5. Procedure
5.1 Identification of Samples for Disposal
- Mark samples for disposal under the following conditions:
- All tests completed and results reviewed
- Retest not applicable
- Sample quantity is exhausted or expired
- Test failed and batch disposition is decided
- QC Analyst to tag sample containers as “FOR DISPOSAL” and update status in the Sample Disposal Register (Annexure-1).
5.2 Documentation Review
- Ensure the following are complete and verified:
- Analytical Worksheet
- Test results and calculations
- OOS/OOT investigation status (if applicable)
- QC Supervisor to verify against the sample logbook and approve disposal.
5.3 Disposal Process
- For solid samples:
- Transfer to designated chemical waste bin lined with polyethylene bag
- Ensure contents are rendered unusable (e.g., moisten with solvent)
- For liquid samples:
- Dilute with large volume of water (if water-soluble and non-hazardous)
- Transfer to the approved effluent disposal tank as per EHS guidelines
- Hazardous samples to be disposed through authorized vendor as per local PCB norms.
5.4 Record and Witness
- Disposal must be witnessed and signed by both the QC Analyst and Supervisor.
- Record the disposal in the Sample Disposal Register (Annexure-1) including:
- Sample ID
- Date of disposal
- Disposal method
- Personnel involved
5.5 Special Cases
- Retained or control samples shall not be disposed unless authorized by QA.
- In case of regulatory holds, dispose only after regulatory clearance.
6. Abbreviations
- QC: Quality Control
- QA: Quality Assurance
- OOS: Out of Specification
- OOT: Out of Trend
- SOP: Standard Operating Procedure
- EHS: Environment, Health and Safety
- PCB: Pollution Control Board
7. Documents
- Sample Disposal Register (Annexure-1)
- Analytical Worksheet
- OOS/OOT Investigation Reports (if applicable)
- Environmental Disposal Logs
8. References
- ICH Q7 – GMP for APIs
- 21 CFR Part 211
- WHO Guidelines on Waste Disposal
- State Pollution Control Board Regulations
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Sample Disposal Register
| Date | Sample ID | Batch No. | Test | Disposal Method | Disposed By | Verified By |
|---|---|---|---|---|---|---|
| 13/04/2025 | SMP-API-123 | API-20250413 | Assay | Incineration | Ravi Kumar | Rajesh Sharma |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Release | GMP Compliance | QA Head |
| 13/04/2025 | 2.0 | Added Hazardous Waste Handling | Audit Observation | QA Head |