Procedures for Handling Out-of-Specification Content Uniformity Results

1) Purpose

The purpose of this SOP is to outline the actions to be taken if content uniformity tests reveal results that are out of specification, ensuring product quality and compliance.

2) Scope

This SOP applies to all content uniformity tests performed on capsules within the pharmaceutical manufacturing facility.

3) Responsibilities

The Quality Control (QC) department is responsible for detecting out-of-specification (OOS) results and initiating corrective actions. The Production department is responsible for implementing the corrective actions.

4) Procedure

1. Detection of OOS Results:
   1. Review the content uniformity test results against the established specifications.
   2. If any result falls outside the acceptable range, document the OOS result in the content uniformity test logbook.
2. Initial Investigation:
   1. Notify the QC manager immediately upon detection of an OOS result.
   2. Conduct a preliminary investigation to identify any obvious errors in the testing process, such as instrument malfunction or operator error.
3. Root Cause Analysis:
   1. If no obvious error is found, perform a detailed root cause analysis to determine the underlying cause of the OOS result.
   2. Examine factors such as raw material quality, manufacturing process parameters, and environmental conditions.
4. Corrective Actions:
   1. Based on the root cause analysis, develop and implement corrective actions to address the issue.
   2. Examples of corrective actions include adjusting manufacturing parameters, retraining operators, and improving raw material inspection procedures.
5. Retesting:
   1. After implementing corrective actions, retest the affected batch of capsules to confirm that the content uniformity meets the specified criteria.
   2. Document the retest results and compare them to the original OOS results.
6. Documentation and Reporting:
   1. Document all findings, corrective actions, and retest results in the content uniformity test logbook and the deviation report.
   2. Submit a final report summarizing the investigation and corrective actions to the QC manager for approval.
7. Preventive Actions:
   1. Review the OOS incident and identify preventive actions to avoid recurrence.
   2. Update SOPs, training materials, and process controls as necessary to incorporate the preventive actions.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Content Uniformity Test Logbook, Deviation Reports, 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