Standard Operating Procedure for Performing Weight Checks Before and After Gel Filling in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/152/2025 |
| Supersedes | SOP/GM/152/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To define the procedure for conducting and documenting weight checks before and after the filling process of gel formulations to ensure uniformity and compliance with pre-established product weight specifications.
2. Scope
This SOP applies to all gel manufacturing batches where manual or automated filling of the finished product is conducted within the production area.
3. Responsibilities
- Production Operator: Carries out the pre-filling and post-filling weight checks as per batch record instructions.
- Production
Supervisor: Verifies the results and ensures corrective action in case of deviation.
QA Executive: Reviews weight check data and performs periodic audits.
4. Accountability
The Head – Manufacturing is accountable for the implementation and maintenance of this SOP and for ensuring that accurate records of weight checks are maintained.
5. Procedure
5.1 Pre-Filling Weight Check
- Ensure balance is calibrated and clean before use.
- Weigh 10 empty containers selected randomly from the lot to establish the average tare weight.
- Document the individual weights and calculate the average tare weight.
5.2 Post-Filling Weight Check
- Immediately after the start of the filling operation, randomly select 10 filled units at different time intervals.
- Record the gross weight of each filled unit using the same balance used for tare weight.
- Deduct the average tare weight to determine net fill weight.
- Ensure that the net weight falls within the specified limits mentioned in the batch manufacturing record (BMR).
5.3 In-Process Checks
- Repeat the weight checks every 30 minutes or as defined in the BMR.
- In case of deviation, stop the line and investigate. Restart only after corrective action.
5.4 Documentation
- All observations shall be recorded in the In-Process Check Record – Annexure-1.
- Ensure entries are made using permanent black ink and corrections are counter-signed with reason and date.
5.5 Line Clearance and QA Oversight
- QA shall perform random verification of weight checks during batch processing.
- Line clearance before filling must include confirmation of scale calibration and availability of weight check records.
6. Abbreviations
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
7. Documents
- In-Process Weight Check Record – Annexure-1
- Balance Calibration Record
- Batch Manufacturing Record
8. References
- Schedule M – GMP Guidelines for Pharmaceuticals
- 21 CFR Part 211 – Subpart G: Packaging and Labeling Control
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: In-Process Weight Check Record Format
| Date | Batch No. | Time | Sample No. | Gross Weight | Tare Weight | Net Weight | Within Limits (Y/N) | Remarks | Operator Sign |
|---|---|---|---|---|---|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 10/04/2022 | 1.0 | Initial Issue | New SOP | QA Head |
| 09/06/2025 | 2.0 | Updated format and annexures, added frequency clarification | Annual Review | QA Head |