Guidelines for Performing Disintegration Tests

1) Purpose

The purpose of this SOP is to provide guidelines for performing disintegration tests to determine how quickly capsules disintegrate in a specified liquid medium.

2) Scope

This SOP applies to all capsules produced within the pharmaceutical manufacturing facility that require disintegration testing.

3) Responsibilities

The Quality Control (QC) department is responsible for conducting disintegration tests and ensuring compliance with the criteria.

4) Procedure

1. Preparation for Testing:
   1. Ensure all disintegration testing equipment is calibrated and clean before use.
   2. Prepare the capsules to be tested according to the test method requirements.
2. Testing Process:
   1. Fill the disintegration apparatus with the specified liquid medium at the required temperature.
   2. Place the capsules in the disintegration apparatus and start the test.
   3. Record the time taken for each capsule to disintegrate completely in the liquid medium.
3. Interpreting Results:
   1. Compare the disintegration times with the specified acceptance criteria for the product.
   2. Document the results of the disintegration test for each capsule.
4. Handling Out-of-Specification Results:
   1. If any capsule fails to disintegrate within the acceptable time range, document the deviation and investigate the cause.
   2. Implement corrective actions to address the deviation and prevent recurrence.
   3. Re-test the capsules after corrective actions to ensure compliance with the disintegration criteria.
5. Documentation and Review:
   1. Record all test results and any deviations in the disintegration test logbook.
   2. Periodically review the disintegration test procedure and acceptance criteria, updating as necessary to ensure ongoing compliance and quality.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Disintegration Test Logbook, Test Methods, and Calibration Records

7) Reference, if any

Relevant regulatory guidelines such as ICH Q7 and FDA Guidance for Industry

8) SOP Version

Version 1.0