Guidelines for Acceptable Content Uniformity

1) Purpose

The purpose of this SOP is to establish criteria for determining acceptable content uniformity in capsules to ensure the even distribution of the active ingredient.

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 establishing and maintaining the criteria for acceptable content uniformity. The Production department is responsible for adhering to these criteria during manufacturing.

4) Procedure

1. Establishing Content Uniformity Criteria:
   1. Determine the acceptable range for active ingredient content in each capsule based on product specifications and regulatory guidelines.
   2. Document the content uniformity criteria in the product specification sheet.
2. Testing for Content Uniformity:
   1. Conduct content uniformity tests as outlined in the content uniformity testing procedure.
   2. Compare the active ingredient content of each capsule to the established criteria.
3. Handling Out-of-Specification Results:
   1. If a capsule’s content is found to be outside the acceptable 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 content uniformity criteria.
4. Documentation and Review:
   1. Record all test results and any deviations in the content uniformity logbook.
   2. Periodically review the content uniformity criteria and update as necessary to ensure ongoing compliance and quality.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Product Specification Sheet, Content Uniformity Logbook, Deviation Reports, and Corrective Action Records

7) Reference, if any

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

8) SOP Version

Version 1.0