Guidelines for Recording and Interpreting Disintegration Test Results

1) Purpose

The purpose of this SOP is to provide procedures for accurately recording and interpreting the results of disintegration tests performed on capsules.

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 recording and interpreting the results of disintegration tests.

4) Procedure

1. Recording Disintegration Test Results:
   1. Immediately record the disintegration time for each capsule in the disintegration test logbook upon completion of the test.
   2. Ensure all entries are legible and accurate, including the date, time, and operator’s initials.
   3. Use only approved and calibrated instruments for measuring disintegration times.
2. Interpreting Disintegration Test Results:
   1. Compare the recorded disintegration times to the established acceptance criteria.
   2. Document any instances where the disintegration time falls outside the acceptable range.
   3. Investigate any out-of-specification results according to the relevant SOP for handling deviations.
3. Data Review and Approval:
   1. The QC manager or designee must review and approve all recorded disintegration test results.
   2. Ensure that all deviations are properly documented and investigated before final approval.
   3. Sign and date the logbook to confirm the review and approval of the test results.
4. Documentation and Archiving:
   1. Maintain all disintegration test records in the designated logbook and ensure they are stored in a secure, easily retrievable location.
   2. Archive the logbook according to the facility’s document retention policy.
   3. Ensure that electronic records, if used, are backed up regularly and comply with regulatory requirements for data integrity.
5. Periodic Review:
   1. Conduct periodic reviews of disintegration test data to identify trends and ensure ongoing compliance with quality standards.
   2. Update the disintegration test procedure and acceptance criteria as necessary based on the review findings.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Disintegration Test Logbook, Deviation Reports, and Data Review Records

7) Reference, if any

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

8) SOP Version

Version 1.0