Guidelines for Conducting Content Uniformity Tests

1) Purpose

The purpose of this SOP is to provide guidelines for conducting content uniformity tests to ensure that the active ingredient is evenly distributed among capsules.

2) Scope

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

3) Responsibilities

The Quality Control (QC) department is responsible for performing content uniformity tests and ensuring compliance with the criteria.

4) Procedure

1. Preparation for Testing:
   1. Ensure all testing equipment is calibrated and clean before use.
   2. Select a representative sample of capsules from the batch to be tested.
2. Testing Process:
   1. Weigh and record the total weight of each capsule.
   2. Disintegrate the capsules and dissolve the contents in a suitable solvent as per the test method.
   3. Analyze the solution using appropriate analytical techniques to determine the active ingredient content.
   4. Record the results of the analysis for each capsule.
3. Calculating Content Uniformity:
   1. Calculate the content uniformity of the batch by comparing the active ingredient content of each capsule to the average content.
   2. Ensure that the content uniformity meets the specified acceptance criteria.
4. Documentation and Review:
   1. Document all test results in the content uniformity logbook.
   2. Review the results to ensure compliance with the acceptance criteria.
   3. Report any deviations to the QC manager and investigate if necessary.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Content Uniformity 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