Standard Operating Procedure for External Audits by Regulatory Bodies

1) Purpose

The purpose of this SOP is to establish procedures for preparing, conducting, and responding to external audits by regulatory bodies to ensure compliance with regulatory requirements and maintain certifications.

2) Scope

This SOP applies to all personnel involved in hosting and managing external audits conducted by regulatory bodies within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Quality Assurance (QA) Team

• Coordinate audit scheduling and logistics.
• Prepare audit documentation and facilities.

3.2 Subject Matter Experts (SMEs)

• Provide necessary documentation and information during audits.
• Address audit findings and observations.

4) Procedure

4.1 Preparing for External Audit

1. Review previous audit reports and corrective actions.
2. Prepare audit response team and assign roles.

4.2 Conducting External Audit

1. Welcome auditors and conduct opening meeting.
2. Provide auditors with access to requested documentation and facilities.
3. Accompany auditors during facility tours and interviews.

4.3 Audit Response and Corrective Actions

1. Document audit findings, observations, and non-conformities.
2. Develop and implement corrective and preventive actions (CAPAs) as needed.

4.4 Closing the Audit

1. Conduct closing meeting with auditors to discuss findings.
2. Submit audit response and CAPA plan within specified timelines.

5) Abbreviations, if any

SOP: Standard Operating Procedure; QA: Quality Assurance; SMEs: Subject Matter Experts; CAPA: Corrective and Preventive Actions

6) Documents, if any

• Previous Audit Reports
• Audit Response Plan
• CAPA Reports

7) Reference, if any

ICH Q9: Quality Risk Management
FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

8) SOP Version

Version 1.0