Standard Operating Procedure for Weight Variation Testing for Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/079/2025 |
| Supersedes | SOP/TAB/079/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To outline the procedure for performing weight variation testing on tablets, ensuring that the tablets conform to the established weight limits set by regulatory standards and internal specifications.
2. Scope
This SOP applies to the weight variation testing of all tablet batches to ensure that the tablets meet the required weight specifications for uniformity.
3. Responsibilities
- Manufacturing Personnel: Responsible for providing representative tablet samples for weight variation testing.
- Quality Control (QC): Responsible for performing weight variation tests, recording results, and ensuring that the tablets meet the required specifications.
- Quality Assurance (QA): Ensures that the weight variation testing is performed according to this SOP and reviews the results for batch release.
4. Accountability
The QC Manager is accountable for ensuring that the weight variation test is conducted in compliance with this SOP and for reporting the results. The QA Manager is responsible for reviewing the results and approving the batch for release.
5. Procedure
5.1 Sample Collection
- Collect a
representative sample of tablets from the batch as specified in the batch record.
The sample should consist of 20 tablets (or as specified in the batch record or pharmacopeial guidelines).
Ensure that the tablets are free from any defects such as cracks, chips, or contamination.
Label the sample appropriately for identification during testing.
5.2 Weighing the Tablets
- Weigh each tablet individually using a calibrated analytical balance.
- Record the weight of each tablet in the batch record (Annexure-1).
- Ensure that the weight of each tablet is recorded accurately to the required decimal places.
5.3 Calculate the Average Weight
- Calculate the average weight of the sample tablets by summing the weights of all the tablets and dividing by the number of tablets.
- Ensure that the average weight falls within the acceptable range as specified in the batch record or pharmacopeial guidelines.
5.4 Calculate the Weight Variation
- Calculate the weight variation for each individual tablet by comparing its weight to the average weight.
- The weight variation should be within the acceptable limits specified by regulatory standards (typically ±10% of the average weight for tablets weighing more than 250 mg, and ±15% for tablets weighing less than 250 mg).
- If more than two tablets fall outside the acceptable weight variation limits, the batch may not meet the weight variation specification, and corrective actions should be taken.
5.5 Documentation and Record-Keeping
- Document the individual tablet weights, average weight, and weight variation in the batch record (Annexure-1).
- Record any deviations from the weight variation specifications in the deviation report (Annexure-2), along with the corrective actions taken.
- Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
5.6 Post-Test Cleanup
- Clean the weighing equipment and any other tools used during the testing procedure according to the manufacturer’s guidelines and the company’s cleaning SOP.
- Ensure that all equipment is properly stored and maintained in good working condition.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
7. Documents
- Batch Record (Annexure-1)
- Deviation Report (Annexure-2)
8. References
- USP <905> – Weight Variation Test
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Weight Variation Test
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Batch Record
| Batch Number | Tablet Sample | Individual Tablet Weight (g) | Average Weight (g) | Weight Variation (%) |
|---|---|---|---|---|
| Batch 001 | 20 tablets | 0.350 | 0.360 | ±5% |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 15/12/2025 | Batch 001 | Tablet weight out of specification | Re-formulated tablet composition | John Doe |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated Weight Variation Criteria | Improved Specifications | QA Head |