Standard Operating Procedure for Disintegration Time Monitoring in In-Process Checks
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/145/2025 |
| Supersedes | SOP/TAB/145/2022 |
| 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 monitoring disintegration time during tablet manufacturing to ensure that the tablets meet the required specifications for proper release and performance.
2. Scope
This SOP applies to the monitoring of disintegration time during the tablet manufacturing process, ensuring tablets disintegrate within the specified time limits to ensure optimal drug release.
3. Responsibilities
- Quality Control (QC): Responsible for conducting disintegration time tests on samples at specified intervals during tablet production.
- Tablet Production Operator: Responsible for sampling tablets at specified intervals and ensuring that tablets are processed correctly for disintegration testing.
- Quality Assurance (QA): Ensures that all disintegration time testing is performed according to the SOP and approves any necessary corrective actions or deviations.
4. Accountability
The QC Manager is accountable for ensuring that disintegration time tests are performed at appropriate stages of the tablet manufacturing process. The QA Manager ensures compliance with all disintegration testing procedures and reviews test results.
5. Procedure
5.1 Sampling
- During the tablet manufacturing process, select a sample of tablets from each batch for disintegration testing.
- Ensure that the sample is taken at regular intervals according to the process schedule to assess disintegration at different stages of production.
5.2 Preparing the Testing Equipment
- Ensure that the disintegration testing apparatus is clean, calibrated, and ready for use according to the manufacturer’s instructions.
- Fill the disintegration vessels with the required temperature-controlled fluid, typically water or simulated gastric fluid (SGF), as per the specifications of the formulation.
- Adjust the temperature of the disintegration bath to 37 ± 1°C to replicate physiological conditions.
5.3 Conducting the Disintegration Test
- Place the tablet samples into the disintegration apparatus, ensuring they are positioned correctly for optimal testing conditions.
- Start the apparatus and monitor the tablets until they have completely disintegrated or the maximum test time is reached, typically 30 minutes.
- Record the time taken for each tablet or batch of tablets to fully disintegrate.
- If a tablet fails to disintegrate within the specified time frame, document the result and initiate an investigation to determine the cause of failure.
5.4 Documentation and Records
- Record the disintegration time for each sample tested in the batch record (Annexure-2) and include any observations or deviations.
- If the disintegration time exceeds the acceptable limit, generate a deviation report (Annexure-1) and review the batch for potential reprocessing or rejection.
- Review the disintegration test results with QA to verify that the tablets meet the required specifications for disintegration time.
5.5 Acceptance Criteria
- The tablets must disintegrate within the specified time, typically within 30 minutes. The exact time limit will depend on the formulation and product requirements.
- If the disintegration time exceeds the specified limit, the batch may need to be rejected or reprocessed, depending on the severity of the deviation.
5.6 Post-Testing Actions
- Once testing is complete and the tablets meet the disintegration requirements, proceed with subsequent processing steps such as drying, coating, and packaging.
- If the tablets fail the disintegration test, initiate corrective actions, which may include adjusting the formulation, reprocessing the batch, or making modifications to the manufacturing process.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- SGF: Simulated Gastric Fluid
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <701> – Disintegration Test for Tablets
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Disintegration 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 | Disintegration time exceeded the limit of 30 minutes | Reprocessed batch and adjusted formulation | John Doe |
Annexure-2: Batch Record
| Sample Number | Disintegration Time | Action Taken |
|---|---|---|
| Sample 1 | 28 min | 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 testing and corrective action process | Improved process compliance | QA Head |