EMA: 2 New Q&As on Third Party Audits of API Suppliers

The European Medicines Agency (EMA) has updated guidance on GMP and GDP. The EMA has added two questions and answers on the basic requirements for active substances used as starting material in relation to third party audits.

1.     Is an audit performed by a third-party acceptable?

According to Union procedures and Article 46(f) of Directive 2001/83/EC, manufacturing authorisation holders (MIA holders) must ensure GMP compliance of their active substance suppliers – either through their own audits or via third-party auditors under appropriate contractual arrangements.

Key points include:

• Audits by MIA holders must be integrated into the quality system, conducted by qualified personnel, and well-documented.
• Third-party audits are permissible, provided Chapter 7 of the EU GMP guidelines is followed and contracts ensure clear roles and responsibilities.
• Conflict of interest (CoI) management is essential: MIA holders must ensure any CoIs are declared, assessed for impact, and documented.
• Potential CoIs may include personal or financial ties, prior employment with the audited company, or commercial interests in audit outcomes.
• Quality systems should support audit integrity, and QPs must evaluate CoI declarations during final audit report assessments.
• These principles also apply to joint audits, where multiple MIA holders share audit arrangements, assuming mutual interest in the active substance.

2.    What are the expectations for the content of written final assessment of third-party audit reports?

Qualified Persons (QPs) bear the ultimate responsibility for ensuring that third-party audit reports are properly evaluated. A written final assessment must clearly summarize this evaluation and be available for review by authorities upon request.
The assessment should cover all relevant aspects of the audit process and report, including:

• Verification of contractual arrangements
• Audit scope, duration, and frequency
• Competence of the auditors in relation to the audit’s scope
• Evaluation of CAPAs and their follow-up
• Consideration of any conflicts of interest

Source:

EMA: Guidance on good manufacturing practice and good distribution practice: Questions and answers