Procedure

5.1 Sampling

1. During the tablet manufacturing process, select a sample of tablets from each batch for disintegration testing.
2. 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

1. Ensure that the disintegration testing apparatus is clean, calibrated, and ready for use according to the manufacturer’s instructions.
2. Fill the disintegration vessels with the required temperature-controlled fluid, typically water or simulated gastric fluid (SGF), as per the specifications of the formulation.
3. Adjust the temperature of the disintegration bath to 37 ± 1°C to replicate physiological conditions.

5.3 Conducting the Disintegration Test

1. Place the tablet samples into the disintegration apparatus, ensuring they are positioned correctly for optimal testing conditions.
2. Start the apparatus and monitor the tablets until they have completely disintegrated or the maximum test time is reached, typically 30 minutes.
3. Record the time taken for each tablet or batch of tablets to fully disintegrate.
4. 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

1. Record the disintegration time for each sample tested in the batch record (Annexure-2) and include any observations or deviations.
2. If the disintegration time exceeds the acceptable limit, generate a deviation report (Annexure-1) and review the batch for potential reprocessing or rejection.
3. Review the disintegration test results with QA to verify that the tablets meet the required specifications for disintegration time.

5.5 Acceptance Criteria

1. The tablets must disintegrate within the specified time, typically within 30 minutes. The exact time limit will depend on the formulation and product requirements.
2. 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

1. Once testing is complete and the tablets meet the disintegration requirements, proceed with subsequent processing steps such as drying, coating, and packaging.
2. 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

1. Batch Record (Annexure-2)
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