Procedures for Documenting and Evaluating Disintegration Test Data

1) Purpose

The purpose of this SOP is to outline the procedures for recording and interpreting disintegration test results to ensure accurate and consistent data documentation and evaluation.

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 accurately recording and interpreting disintegration test results.

4) Procedure

1. Recording Test Results:
   1. Document the time taken for each capsule to disintegrate completely in the liquid medium in the disintegration test logbook.
   2. Ensure that all entries are made in real-time and are accurate and legible.
2. Reviewing Test Results:
   1. Compare the recorded disintegration times with the specified acceptance criteria for the product.
   2. Identify any results that do not meet the acceptance criteria and document these as deviations.
3. Interpreting Results:
   1. Analyze the disintegration data to identify trends or patterns that may indicate potential issues in the manufacturing process.
   2. Prepare a summary report of the disintegration test results, including any deviations and corrective actions taken.
4. Documentation:
   1. Maintain all disintegration test records, including raw data, logbook entries, and summary reports, in a secure and organized manner.
   2. Ensure that all documentation is reviewed and approved by the QC manager.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Disintegration Test Logbook, Summary Reports, and Deviation Reports

7) Reference, if any

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

8) SOP Version

Version 1.0