Standard Operating Procedure for Transfer of Final Bulk Elixir for Bottling
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/099/2025 |
| Supersedes | SOP/ELX/099/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define a standardized procedure for the safe, hygienic, and documented transfer of final bulk elixir from the manufacturing area to the bottling/filling section to maintain product integrity and traceability.
2. Scope
This SOP applies to all final elixir products in bulk form approved for bottling in the Elixir Department, including those held in manufacturing or intermediate holding tanks.
3. Responsibilities
- Production Operator:
- Perform transfer as per SOP and ensure all connections are clean and sanitized.
- Production Supervisor:
- Verify line clearance and approve transfer initiation.
- QA Officer:
- Approve product for bottling and verify line clearance and labeling.
4. Accountability
The Head of Production is accountable for ensuring safe, GMP-compliant transfer of final elixir product to the bottling area, maintaining documentation and batch traceability.
5. Procedure
5.1 Prerequisites
- Ensure the batch is
approved by QC and QA for further processing.
Verify volume as per BMR and confirm product identity labeling on the transfer container.
Complete line clearance of the bottling area and record it in the Line Clearance Record (Annexure-1).
5.2 Transfer Line Setup
- Ensure all hoses, pipes, pumps, and transfer tanks are cleaned, sanitized, and dried.
- Use dedicated and labeled transfer lines or thoroughly cleaned multipurpose lines.
- Ensure transfer path is as short as possible to minimize exposure risk.
5.3 Transfer Process
- Initiate transfer using gravity or low-pressure pump depending on layout.
- Maintain a closed-loop transfer system to prevent contamination or evaporation loss.
- Monitor flow rate and avoid foaming or splashing during transfer.
- Label the receiving tank or holding vessel with product name, batch number, and status (“Ready for Bottling”).
5.4 Post-Transfer Activities
- Flush the transfer line with a small quantity of the same product and add it back to the main batch if applicable.
- Clean and dry all equipment and lines used for transfer immediately after completion.
- Record all details in the Transfer Log (Annexure-2).
5.5 Documentation
- Document the following in BMR and Annexure-2:
- Transfer date and time
- Volume transferred
- Operator and supervisor signatures
- Transfer line ID
- QA shall verify product label and sign the log before bottling begins.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- QC: Quality Control
7. Documents
- Line Clearance Record (Annexure-1)
- Bulk Transfer Log (Annexure-2)
- Batch Manufacturing Record (BMR)
8. References
- 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
- WHO 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: Line Clearance Record
| Date | Area | Cleared By | Checked By (QA) | Remarks |
|---|---|---|---|---|
| 11/04/2025 | Bottling Area – Line 2 | Rajesh Kumar | Sunita Reddy | No previous material residues |
Annexure-2: Bulk Transfer Log
| Date | Batch No. | Volume Transferred (L) | Transfer Line ID | Operator | Supervisor | QA Verified |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1038 | 995 L | TL-05 | Rajesh Kumar | Meena Sharma | 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 | QA Head |
| 11/04/2025 | 2.0 | Added Annexures and clarified transfer validation steps | Process Compliance Update | QA Head |