Standard Operating Procedure for Performing Weight Variation Testing on Gel-Filled Packaging Units
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/069/2025 |
| Supersedes | SOP/GM/069/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 02/06/2025 |
| Effective Date | 04/06/2025 |
| Review Date | 02/06/2026 |
1. Purpose
To define the procedure for conducting weight variation tests on gel-filled packaging units (e.g., tubes, jars, sachets) to ensure each unit complies with the fill weight specifications.
2. Scope
This procedure applies to all gel products packaged in individual units
at the Gel Manufacturing department.
3. Responsibilities
- Production Operator: Responsible for sampling and weighing of filled units.
- QA Analyst: Responsible for verifying the accuracy and maintaining records.
- Head – Manufacturing: Accountable for ensuring procedural adherence.
4. Accountability
QA department shall be accountable for ensuring all results are documented and deviations investigated, if applicable.
5. Procedure
5.1 Sampling
- Select 10 samples randomly from each packaging batch.
- Ensure that samples are collected after the filling machine has stabilized.
5.2 Equipment and Materials
- Analytical balance (calibrated)
- Weighing boats or trays
- Scissors for emptying content (if needed)
- Weight Variation Logbook (Annexure-1)
5.3 Procedure
- Weigh the filled container (gross weight) and record.
- Empty the entire content of the container and weigh the empty container (tare weight).
- Calculate the net weight: Gross weight – Tare weight.
- Record all weights in the logbook.
- Compare with the labeled claim and permissible limits (±5% unless otherwise specified).
5.4 Acceptance Criteria
- Minimum 9 out of 10 units must comply with the ±5% limit.
- None of the samples should exceed ±10% variation.
5.5 Rejection Criteria
- More than one sample deviating beyond ±5%.
- Any sample showing deviation beyond ±10%.
5.6 Actions on Failure
- Hold the batch and initiate deviation form (Annexure-2).
- Investigate potential root cause (filler calibration, operator error, tube malfunction, etc.).
- Rework batch if feasible and authorized by QA.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- GMP: Good Manufacturing Practice
7. Documents
- Weight Variation Logbook – Annexure-1
- Deviation Report – Annexure-2
8. References
- WHO TRS 986, Annex 2 – GMP for Pharmaceutical Products
- In-house product specification file
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: Weight Variation Logbook Format
| Batch No. | ||||||
|---|---|---|---|---|---|---|
| Product Name | ||||||
| Date | ||||||
| Sample No. | Gross Weight (g) | Tare Weight (g) | Net Weight (g) | Labeled Claim (g) | Deviation (%) | Result |
| 1 | [ ] Pass [ ] Fail |
Annexure-2: Deviation Report Format
| Deviation ID | |
|---|---|
| Date of Detection | |
| Product Name | |
| Batch Number | |
| Nature of Deviation | |
| Investigated By | |
| Root Cause | |
| Corrective Action | |
| Approved By |
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 15/06/2022 | 1.0 | Initial version | New SOP | QA Head |
| 02/06/2025 | 2.0 | Updated rejection criteria and added annexures | Periodic Review | QA Head |