Standard Operating Procedure for Uniformity of Dosage Units Testing in Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/074/2025 |
| Supersedes | SOP/TAB/074/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 20/02/2026 |
| Effective Date | 25/02/2026 |
| Review Date | 20/02/2027 |
1. Purpose
To provide a standardized procedure for testing the uniformity of dosage units in tablets, ensuring that each tablet contains the correct amount of active pharmaceutical ingredient (API) within the established limits.
2. Scope
This SOP applies to the testing of uniformity of dosage units for all tablet batches, ensuring consistent distribution of the active ingredient throughout the batch.
3. Responsibilities
- Manufacturing Personnel: Responsible for providing the tablet samples for uniformity testing and ensuring that the correct number of tablets are selected for the test.
- Quality Control (QC): Responsible for conducting the uniformity of dosage units test, recording the results, and ensuring compliance with the batch specifications.
- Quality Assurance (QA): Ensures that the testing process is followed correctly and reviews the results for final batch approval.
4. Accountability
The QC Manager is accountable for ensuring that the uniformity of dosage units test is conducted according to this SOP and for reporting the results. The QA
Manager is responsible for reviewing the test 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 10 tablets or as specified in the batch record or pharmacopeial guidelines.
- Ensure that the sample is free from defects such as cracks, chips, or any other visible damage.
- 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 Testing for Uniformity of Dosage Units
- Calculate the average weight of the 10 tablets.
- Ensure that the average weight of the tablets is within the acceptable limits as specified in the batch record or pharmacopeial guidelines (e.g., 85% – 115% of the labeled amount of active ingredient).
- Determine the deviation of each individual tablet’s weight from the average weight and calculate the percentage deviation.
- If more than two tablets fall outside the acceptable deviation range, the batch does not meet the uniformity of dosage units specification, and corrective action should be taken.
5.4 Uniformity of Content Test
- If the weight variation is acceptable, perform a content uniformity test on the sample tablets, if required, according to the pharmacopeial guidelines (e.g., USP <905> for content uniformity testing).
- Measure the active ingredient content in each tablet using an appropriate analytical method (e.g., HPLC, UV spectrophotometry).
- Ensure that the content in each tablet falls within the acceptance criteria (e.g., 85% to 115% of the labeled amount of API).
- If the content uniformity fails, document the deviation in the deviation report (Annexure-2) and take corrective actions as necessary.
5.5 Documentation and Record-Keeping
- Record the results of the uniformity of dosage units test, including the weight of each tablet, the average weight, percentage deviation, and the results of the content uniformity test, in the batch record (Annexure-1).
- Document any deviations from the specified limits in the deviation report (Annexure-2), along with the corrective actions taken.
- Ensure 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 testing 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> – Uniformity of Dosage Units
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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 | Initial Weight (g) | Final Weight (g) | Weight Deviation (%) | Content Uniformity (%) |
|---|---|---|---|---|---|
| Batch 001 | 10 tablets | 250 mg | 245 mg | 1.2% | 98% |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 12/12/2025 | Batch 001 | Tablet weight out of specification | Re-formed tablets | 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 Testing Parameters | Improved Testing Method | QA Head |