Guidelines for Performing Disintegration Tests on Capsules

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 disintegration tests conducted on capsules within the pharmaceutical manufacturing facility.

3) Responsibilities

The Quality Control (QC) department is responsible for conducting disintegration tests and recording the results.

4) Procedure

1. Preparation for Disintegration Testing:
   1. Ensure that the disintegration testing apparatus is calibrated and clean.
   2. Prepare the liquid medium according to the test method requirements.
   3. Label and prepare the capsules to be tested.
2. Performing the Disintegration Test:
   1. Place the capsules in the disintegration apparatus.
   2. Immerse the capsules in the liquid medium and start the apparatus.
   3. Record the time taken for each capsule to disintegrate completely.
3. Recording and Interpreting Results:
   1. Document the disintegration times for each capsule in the disintegration test logbook.
   2. Compare the results to the specified acceptance criteria.
   3. If any capsule fails to disintegrate within the acceptable time range, document the deviation and investigate the cause.
4. Handling Deviations:
   1. Identify and document any deviations from the specified acceptance criteria.
   2. Conduct a root cause analysis to determine the reason for the deviation.
   3. Implement corrective actions to address the deviation and prevent recurrence.
5. Documentation and Review:
   1. Record all test results and any deviations in the disintegration test logbook.
   2. Review and approve the test results and corrective actions.
   3. Periodically review the disintegration test procedure and acceptance criteria, updating as necessary.

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