Standard Operating Procedure for Internal Audits of Manufacturing Processes

1) Purpose

The purpose of this SOP is to outline procedures for conducting internal audits of manufacturing processes to verify compliance with regulatory requirements, identify areas for improvement, and ensure consistent product quality.

2) Scope

This SOP applies to all personnel involved in conducting and participating in internal audits within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Quality Assurance (QA) Team

• Plan and schedule internal audit activities.
• Perform audits according to established audit plans.

3.2 Operations and Quality Control (QC) Personnel

• Participate in audit interviews and provide relevant documentation.
• Implement corrective actions as directed by audit findings.

4) Procedure

4.1 Audit Planning

1. Define audit objectives, scope, and criteria.
2. Prepare audit checklists based on regulatory requirements and best practices.

4.2 Conducting Audits

1. Conduct opening meetings with auditees to explain audit process and objectives.
2. Review documentation and records related to manufacturing processes.
3. Perform walkthrough inspections of manufacturing areas.

4.3 Audit Reporting

1. Document audit findings, observations, and non-conformities.
2. Issue audit reports and communicate findings to management and relevant stakeholders.

4.4 Corrective Actions and Follow-Up

1. Assign corrective actions to address identified non-conformities.
2. Verify effectiveness of corrective actions through follow-up audits.

5) Abbreviations, if any

SOP: Standard Operating Procedure; QA: Quality Assurance; QC: Quality Control

6) Documents, if any

• Internal Audit Plan and Checklist
• Audit Reports and Findings
• Corrective Action Requests (CARs)

7) Reference, if any

ICH Q10: Pharmaceutical Quality System
FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

8) SOP Version

Version 1.0