Standard Operating Procedure for Dissolution Testing for First Batch Release of Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/137/2025 |
| Supersedes | SOP/TAB/137/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedure for performing dissolution testing on the first batch of tablets before release to ensure that the tablets meet the required dissolution profile for proper drug release and bioavailability.
2. Scope
This SOP applies to the dissolution testing of the first batch of tablets after manufacturing. The testing ensures that the tablets meet the required dissolution specifications and are ready for release into the market or further stages of production.
3. Responsibilities
- Quality Control (QC): Responsible for conducting the dissolution testing on the first batch of tablets to ensure compliance with dissolution criteria.
- Tablet Production Operator: Responsible for providing tablets for dissolution testing after the batch is manufactured and ensuring proper handling during the testing process.
- Quality Assurance (QA): Ensures that the dissolution testing procedure is followed correctly and reviews the test results for compliance with specifications.
4. Accountability
The QC Manager is accountable for ensuring dissolution testing is performed accurately and according to this SOP. The QA Manager is responsible for reviewing the test results and ensuring they meet the established quality standards.
5. Procedure
5.1 Tablet Sampling
- For the first batch release, select a representative sample of tablets from different locations of the batch (top, middle, and bottom) to ensure consistency across the entire batch.
- Ensure that the sample size meets the required quantity as per regulatory guidelines, typically 6 tablets per batch for dissolution testing.
- Weigh the tablets before starting the test and record the initial weight for reference.
5.2 Preparation of Dissolution Apparatus
- Prepare the dissolution apparatus according to the manufacturer’s instructions. Ensure that the equipment is calibrated, clean, and ready for use.
- Select the appropriate dissolution medium based on the tablet formulation and regulatory requirements (e.g., water, buffer solution, or simulated gastric fluid).
- Ensure that the dissolution medium is at the specified temperature (usually 37°C ± 0.5°C) and that the apparatus is set to the correct rotational speed (typically 50 or 75 rpm, depending on the tablet type).
5.3 Dissolution Testing Procedure
- Place one tablet into each of the dissolution vessels and start the apparatus.
- At specified time intervals (e.g., 5, 10, 15, 30, 45, and 60 minutes), withdraw a sample of the dissolution medium from each vessel using a syringe or pipette.
- Filter the sample to remove any undissolved particles and store the filtered solution for further analysis.
- Measure the drug concentration in the sample using an appropriate analytical method, such as UV-Vis spectrophotometry, HPLC, or another validated technique.
5.4 Calculation and Evaluation of Dissolution Data
- Plot the cumulative percentage of drug dissolved against time for each sample taken at the specified intervals.
- Compare the dissolution profile of the first batch with the pre-established dissolution criteria. The percentage of drug dissolved at each time point should meet the specifications outlined in the product’s monograph or regulatory guidelines.
- The tablets must demonstrate a consistent and complete release of the active ingredient within the defined time frame (e.g., 80% of the drug should be dissolved within 60 minutes for immediate-release tablets).
5.5 Monitoring and Adjustments
- If the dissolution profile fails to meet the specified criteria, perform troubleshooting on the batch, such as re-evaluating the manufacturing process (e.g., blending or compression force), or checking for potential issues with the dissolution apparatus.
- If necessary, adjust the formulation or manufacturing process and re-test a new sample of the batch.
5.6 Documentation
- Document the dissolution testing results, including the sample number, dissolution times, drug concentration, and any adjustments made in the batch record (Annexure-2).
- Document any deviations from the standard dissolution profile and corrective actions in the deviation report (Annexure-1).
- Ensure that all records are signed, dated, and reviewed by QA for compliance with quality standards.
5.7 Acceptance Criteria
- The tablets should meet the established dissolution criteria for the active ingredient’s release profile.
- For immediate-release tablets, typically 80% of the drug should dissolve within 60 minutes. Adjust the criteria as per the specific product requirements.
- If the tablets fail to meet the dissolution criteria, they must be rejected, and corrective actions should be taken to address the issues.
5.8 Post-Testing Actions
- If the tablets meet the dissolution criteria, proceed with the next steps in the tablet release process, including packaging, labeling, and distribution.
- Ensure that the dissolution apparatus is cleaned, calibrated, and maintained regularly as per the equipment maintenance schedule.
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-2)
- Deviation Report (Annexure-1)
8. References
- USP <711> – Dissolution Testing of Tablets and Capsules
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Dissolution Testing for Tablets
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 15/12/2025 | Batch 001 | Dissolution rate below 80% at 60 minutes | Adjusted granulation parameters and re-sampled | John Doe |
Annexure-2: Batch Record
| Sample Number | Dissolution Results | Action Taken |
|---|---|---|
| Sample 1 | Pass (Dissolution rate 85% at 60 minutes) | Accepted |
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 dissolution testing process | Improved testing accuracy | QA Head |