Standard Operating Procedure for External Audits

1) Purpose

The purpose of this SOP is to define the procedure for preparing, conducting, and managing external audits conducted by regulatory authorities or external auditors to ensure compliance with regulatory requirements and quality standards.

2) Scope

This SOP applies to all departments and processes within the pharmaceutical manufacturing facility subject to external audits.

3) Responsibilities

3.1 Quality Assurance (QA) Manager
– Coordinate and facilitate external audits.
– Ensure readiness of the facility and personnel for audits.
3.2 Department Heads
– Cooperate with auditors during audits and provide necessary documentation and information.
3.3 Regulatory Affairs
– Serve as the primary contact for regulatory auditors.
– Ensure compliance with regulatory requirements and facilitate audit responses.

4) Procedure

4.1 Audit Notification
4.1.1 Receive notification of upcoming external audit from regulatory authorities or external auditors.
4.1.2 Inform relevant departments and personnel about the audit schedule and requirements.
4.2 Pre-Audit Preparation
4.2.1 Review previous audit reports and address any outstanding audit findings.
4.2.2 Conduct internal pre-audit activities, including mock audits, to assess readiness.
4.3 Audit Execution
4.3.1 Provide auditors with access to facilities, documents, and personnel as required.
4.3.2 Accompany auditors during facility tours and provide explanations as needed.
4.4 Audit Response
4.4.1 Document audit findings, observations, and any corrective actions required.
4.4.2 Prepare responses to audit findings and submit them within specified timelines.
4.5 Follow-Up Actions
4.5.1 Implement corrective actions as directed based on audit findings and recommendations.
4.5.2 Monitor and track the implementation and effectiveness of corrective actions.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– Audit Notification
– Audit Reports (External)
– Audit Response Plans

7) Reference, if any

– FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
– ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0