Standard Operating Procedure for Handling Return of Materials after Dispensing in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/036/2025 |
| Supersedes | SOP/ELX/036/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
This SOP outlines the procedure for managing returned materials after partial dispensing during elixir manufacturing. It ensures proper handling, identification, storage, and documentation of returned raw materials to maintain their quality and traceability.
2. Scope
This SOP applies to all returned raw materials, excipients, and solvents that remain unused after dispensing operations in the Elixir Department and are returned to the warehouse or storage area.
3. Responsibilities
- Dispensing Operator:
- Return unused material immediately after dispensing with intact labeling and seals.
- Warehouse Staff:
- Verify the return condition and quantity, and reassign proper storage location.
- QA Personnel:
- Inspect and approve return for reuse or recommend rejection.
- Maintain return records and ensure traceability.
4. Accountability
The Warehouse In-Charge is accountable for ensuring that returned materials are handled as per this SOP and comply with GMP and traceability requirements.
5. Procedure
5.1 Immediate Return after Dispensing
- After completing dispensing, the operator shall seal the remaining material using its original closure system.
- Label the container with a “Returned Material” tag, including:
- Material Name
- Batch Number
- Returned Quantity
- Date
- Dispensing Reference Number
- Submit the material along with the filled Material Return Slip to the warehouse.
5.2 Warehouse Verification
- Warehouse personnel shall:
- Verify physical integrity of the container and seal.
- Cross-check quantity returned with the dispensing logbook.
- Confirm labeling and accompanying documentation.
- Reject the material if there are signs of tampering, contamination, or labeling discrepancies.
5.3 Quality Assurance Review
- QA shall:
- Inspect the condition of the returned material.
- Determine if the material is reusable based on visual and documented review.
- Approve or reject the material by signing the Return Slip and recording the decision.
5.4 Storage and Status Update
- Store approved returned material in its original storage conditions with proper identification label (e.g., “Partially Used – Approved”).
- Update the inventory control system with the returned quantity and status.
- Rejected materials should be moved to the “Rejected Area” and documented in the Non-Conformance Register.
5.5 Documentation
- Record details of returned materials in the Material Return Register (Annexure-1).
- Attach a copy of the Certificate of Analysis (CoA) if required by QA (Annexure-2).
- Maintain the Return Approval Form signed by QA (Annexure-3).
6. Abbreviations
- QA: Quality Assurance
- CoA: Certificate of Analysis
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
7. Documents
- Material Return Register (Annexure-1)
- Certificate of Analysis (Annexure-2)
- Return Approval Form (Annexure-3)
8. References
- 21 CFR Part 211 – Good Manufacturing Practices for Finished Pharmaceuticals
- WHO TRS 986 Annex 2 – GMP Guidelines for Pharmaceutical Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Material Return Register
| Date | Material | Batch No. | Qty Returned | Returned By | Condition | QA Status |
|---|---|---|---|---|---|---|
| 11/04/2025 | Sodium Saccharin | SS9911 | 0.300 kg | Rajesh Kumar | Intact | Approved |
Annexure-2: Certificate of Analysis (CoA)
| Material | Batch No. | Test | Result | Complies |
|---|---|---|---|---|
| Sodium Saccharin | SS9911 | Assay | 100.1% | Yes |
Annexure-3: Return Approval Form
| Date | Material | Batch No. | Returned By | Reviewed By (QA) | Disposition |
|---|---|---|---|---|---|
| 11/04/2025 | Sodium Saccharin | SS9911 | Rajesh Kumar | Sunita Reddy | Reusable – Approved |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Version | Document Creation | QA Head |
| 11/04/2025 | 2.0 | Included Return Labeling and Disposition Flow | Audit Recommendation | QA Head |