External GMP Audits: Requirements, Procedure, and Auditor Qualifications

GMP regulations in the EU and the USA require manufacturers to maintain a quality system that includes regular audits. While EU legislation mandates both self-inspections and external audits, including supplier audits for active substances (Directive 2001/83/EC, Chapter 5.29), U.S. regulations recommend risk-based supplier audits under the FDA’s Quality Systems Approach guidance. External audits assess compliance by an independent body and can take the form of customer audits (second-party), third-party audits by certification bodies, or regulatory inspections.

Audit Procedure: Planning defines scope, objectives, and schedule. The opening meeting introduces the team and audit purpose. On-site activities include inspection of facilities, review of quality systems, staff interviews, and evidence collection. Findings are presented at a closing meeting. The audit report documents deviations, and corrective actions with timelines are required, with follow-up audits if necessary.

Auditor Qualifications: Auditors should have a degree in a relevant field, GMP regulatory expertise, practical experience, training in audit methodology, and soft skills such as communication and analytical thinking. New auditors typically co-audit with experienced personnel. Continuous professional development is recommended through courses, conferences, or professional networks.

01-12-2025