Standard Operating Procedure for Weight Verification Before Final Transfer in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/115/2025 |
| Supersedes | SOP/ELX/115/2022 |
| 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 standard procedure for verifying the weight of the final bulk elixir before transferring it for storage, filtration, or filling to ensure batch integrity, accountability, and compliance with GMP requirements.
2. Scope
This SOP applies to all final product bulk solutions in the Elixir Department prior to transfer for further processing or packaging.
3. Responsibilities
- Production Operator:
- Carry out weighing procedures using calibrated balances and record values.
- Production Supervisor:
- Verify final weight records and approve for next step.
- QA Officer:
- Review verification documentation and confirm batch weight accuracy.
4. Accountability
The Head of Production is accountable for ensuring the final weight verification is accurate, documented, and cross-checked before any product transfer or filtration.
5. Procedure
5.1 Preparation
- Ensure the final mixing or holding vessel is labeled and the batch
is completed as per BMR instructions.
Clean and calibrate the weighing balance used for weight verification (verify calibration sticker is valid).
5.2 Weighing Process
- Record the tare weight of the empty receiving container(s) before transfer.
- Start transfer of the final bulk solution from the mixing tank to the container using a sterile transfer line or pump.
- After transfer is complete, weigh each filled container individually.
- Calculate the net weight of the bulk elixir in each container by subtracting the tare weight.
- Sum all net weights to determine the total final batch weight.
5.3 Verification
- Compare the final weight with theoretical batch yield as per BMR.
- Ensure the variation is within ±2% of theoretical weight, unless otherwise justified and approved.
- If discrepancy is observed:
- Stop further operations
- Initiate deviation investigation
- Record all weight entries in the Final Weight Verification Log (Annexure-1).
5.4 Documentation and Approval
- Production Supervisor to review and sign off on weight records.
- QA Officer to verify compliance and approve further processing or transfer.
- Attach a copy of the weight log to the BMR.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
7. Documents
- Final Weight Verification Log (Annexure-1)
- Balance Calibration Log
- Batch Manufacturing Record (BMR)
8. References
- WHO TRS 986 – GMP Guidelines
- 21 CFR Part 211.101 – Calculation of Yield
- Internal SOP on Equipment Calibration
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Final Weight Verification Log
| Date | Batch No. | Container No. | Tare Weight (kg) | Gross Weight (kg) | Net Weight (kg) | Operator | Supervisor |
|---|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1050 | C1 | 5.0 | 35.0 | 30.0 | Rajesh Kumar | 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 | Clarified verification limits and documentation flow | Yield Control Improvement | QA Head |