Procedures for Addressing Content Uniformity Issues

1) Purpose

The purpose of this SOP is to outline the actions to be taken when content uniformity of capsules is found to be out of specification, including documentation and investigation procedures.

2) Scope

This SOP applies to all capsules produced within the pharmaceutical manufacturing facility that are found to have out-of-specification (OOS) content uniformity results.

3) Responsibilities

The Quality Control (QC) department is responsible for identifying content uniformity issues and implementing corrective actions. The Production department is responsible for addressing and documenting these issues.

4) Procedure

1. Identification of Content Uniformity Issues:
   1. During routine content uniformity tests, identify any capsules that fall outside the acceptable range.
   2. Document the non-conforming results in the content uniformity logbook.
2. Immediate Actions:
   1. Isolate the affected batch or lot of capsules to prevent further processing or distribution.
   2. Notify the QC manager and relevant personnel about the content uniformity issue.
3. Investigation:
   1. Conduct a thorough investigation to determine the root cause of the content uniformity issue.
   2. Review the manufacturing process, equipment calibration records, and operator logs for potential causes.
   3. Document the findings of the investigation in a deviation report.
4. Corrective and Preventive Actions (CAPA):
   1. Develop and implement corrective actions to address the identified root cause.
   2. Implement preventive actions to avoid recurrence of the content uniformity issue.
   3. Verify the effectiveness of the corrective and preventive actions by re-testing a sample of capsules from the affected batch.
5. Documentation:
   1. Record all actions taken, including isolation, investigation, CAPA, and re-testing results, in the content uniformity logbook and deviation report.
   2. Update the batch record and quality control documents to reflect the resolution of the issue.

5) Abbreviations, if any

QC: Quality Control

CAPA: Corrective and Preventive Actions

6) Documents, if any

Content Uniformity Logbook, Deviation Reports, Investigation Records, and CAPA Documentation

7) Reference, if any

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

8) SOP Version

Version 1.0