Standard Operating Procedure for Labeling of Recovered Solvents with Batch Information in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/044/2025 |
| Supersedes | SOP/API/044/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a procedure for labeling of recovered solvents with complete batch information to ensure traceability, clear identification, and regulatory compliance during storage, transfer, and reuse in API manufacturing.
2. Scope
This SOP applies to all recovered solvents collected, purified, tested, and stored within the API manufacturing facility. It includes labeling during and after solvent recovery, prior to reuse or disposal.
3. Responsibilities
- Production Personnel: Affix appropriate labels on recovered solvent containers.
- QA Department: Verify label accuracy and approve container release for use.
- Warehouse Personnel: Ensure labeled drums are stored in designated areas as per SOP.
4. Accountability
The Production Head is accountable for proper labeling practices. QA Head is responsible for verification and traceability control.
5. Procedure
5.1 Label Preparation
- Labels shall be printed using approved formats from the QA-approved template.
- Labels shall be waterproof, non-smudging, legible, and securely affixed to the drum or storage container.
- Label color-coding may be used (e.g., green for “Approved for Reuse,” red for “Rejected”).
5.2 Label Content
Each recovered solvent label must include the following details:
- “Recovered Solvent” – prominently displayed
- Solvent Name (e.g., Methanol, Acetone)
- Recovered Batch No. (e.g., RCV-202504)
- Original Source Batch No. (e.g., API-202504)
- Date of Recovery
- Volume (in Liters)
- Purity % (post-QC approval)
- Status: “Approved for Reuse” or “Rejected”
- QC Approval Date & Signature (for approved drums)
5.3 Labeling Steps
- Once QC approves the solvent, print and affix the label to each filled drum or container.
- Ensure labels are placed on the front-facing, easily visible side of the container.
- Use indelible markers to fill in any handwritten data (if required).
- Double-check for batch mismatch, missing information, or incorrect status before storage.
5.4 Storage and Control
- Store recovered solvents with labels facing outward for visibility and traceability.
- Drums without proper labels must not be moved into production or reused.
- Maintain the “Recovered Solvent Label Log” (Annexure-1) for every label issued or reissued.
6. Abbreviations
- SOP: Standard Operating Procedure
- QC: Quality Control
- QA: Quality Assurance
- RCV: Recovered Solvent Batch Number
- API: Active Pharmaceutical Ingredient
7. Documents
- Recovered Solvent Label Template (Annexure-1)
- Recovered Solvent Label Log (Annexure-2)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- 21 CFR Part 211 – Labeling and Packaging Controls
- WHO GMP Guide – Section 12 (Materials Management)
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Recovered Solvent Label Template
| Recovered Solvent | |
|---|---|
| Solvent Name | Methanol |
| Recovered Batch No. | RCV-202504 |
| Source Batch No. | API-202504 |
| Date of Recovery | 13/04/2025 |
| Volume | 100 L |
| Purity | 99.7% |
| Status | Approved for Reuse |
| QC Approval Date | 13/04/2025 |
Annexure-2: Recovered Solvent Label Log
| Date | Solvent | Batch No. | Label Issued By | Remarks |
|---|---|---|---|---|
| 13/04/2025 | Methanol | RCV-202504 | First Issue |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Release | New GMP Requirement | QA Head |
| 13/04/2025 | 2.0 | Label format updated; Annexures added | Documentation Standardization | QA Head |