Standard Operating Procedure for Disposal of Rejected or Contaminated Materials in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/017/2025 |
| Supersedes | SOP/API/017/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a standardized procedure for the safe, secure, and compliant disposal of rejected or contaminated raw materials, intermediates, and final APIs to prevent accidental use or environmental harm.
2. Scope
This SOP applies to all rejected and/or contaminated materials—raw, in-process, or finished—identified in the warehouse or production areas of the API manufacturing unit.
3. Responsibilities
- Warehouse/Production Personnel: Identify and segregate rejected or contaminated materials.
- QA Officer: Evaluate material status, authorize disposal, and verify disposal documentation.
- EHS Officer: Ensure safe disposal as per environmental and regulatory guidelines.
4. Accountability
The QA Head and EHS Manager are jointly accountable for verifying that rejected or contaminated materials are safely and irreversibly disposed of with appropriate documentation.
5. Procedure
5.1 Identification of Rejected/Contaminated Materials
- Materials may be considered for disposal due to:
- OOS (Out of Specification) test results
- Label mix-up or misidentification
- Microbial/chemical contamination
- Physical damage (e.g., torn packaging, leakage)
- Expired or re-test failed materials
- Label such items as “REJECTED – DO NOT USE” with red-colored tags.
- Record material details in the “Rejected Material Register” (Annexure-1).
5.2 Segregation and Quarantine
- Transfer materials to a designated “Rejected Material Area” secured with restricted access.
- Do not allow rejected items to remain in general storage or dispensing areas.
- Keep them physically separated by type (solids/liquids/flammables) in labeled bins or pallets.
5.3 Evaluation and Disposal Authorization
- Prepare a “Material Disposal Request Form” (Annexure-2) with:
- Material type and batch number
- Reason for rejection
- Quantity to be disposed
- QA will evaluate the request and approve or reject disposal based on investigation outcome.
5.4 Disposal Methods
- Disposal shall be done in presence of QA & EHS personnel via:
- Incineration (flammables, toxic chemicals)
- Neutralization followed by drainage (as per MSDS)
- Secure landfill (solids, non-toxic material)
- Return to vendor (where applicable)
- Use approved third-party waste management agencies if required and retain certificates.
5.5 Documentation and Record-Keeping
- Maintain “Disposal Record Log” (Annexure-3) signed by all involved parties.
- Retain the following:
- Disposal request
- Investigation report
- Disposal certificate (if external agency used)
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- EHS: Environment, Health & Safety
- OOS: Out of Specification
- MSDS: Material Safety Data Sheet
7. Documents
- Rejected Material Register (Annexure-1)
- Material Disposal Request Form (Annexure-2)
- Disposal Record Log (Annexure-3)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- 21 CFR Part 211.192 – Production Record Review
- WHO TRS 957 Annex 5 – Disposal of Waste in Pharmaceutical Facilities
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Rejected Material Register
| Date | Material | Batch No. | Reason for Rejection | Qty | Entered By |
|---|---|---|---|---|---|
| 13/04/2025 | Sodium Hydroxide | SH202504 | Contaminated | 10 kg |
Annexure-2: Material Disposal Request Form
| Material | Batch No. | Reason | Qty | Requested By | Approved By (QA) |
|---|---|---|---|---|---|
| Sodium Hydroxide | SH202504 | Moisture contamination | 10 kg |
Annexure-3: Disposal Record Log
| Date | Material | Batch | Method | Qty | Disposal Done By | Verified By (QA) |
|---|---|---|---|---|---|---|
| 14/04/2025 | Sodium Hydroxide | SH202504 | Neutralization | 10 kg |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Release | GMP Requirement | QA Head |
| 13/04/2025 | 2.0 | Expanded Disposal Categories and Record Requirements | Audit Recommendation | QA Head |