API audits to assess GMP compliance

Diapharm ensures that suppliers of APIs, starting materials and excipients are audited in a cost-efficient manner. Through Europe’s first accredited inspection body (type A) for active pharmaceutical ingredients, we are able to conduct independent, high-quality audits of API suppliers anywhere in the world.

We guarantee

API audits by qualified auditors
Comprehensive API audit reports
Highest quality and absolute independence (type A accredited)
Confidentiality on all levels and guaranteed absence of conflict of interest
Assessment of CAPA plan and CAPA declaration
All costs included (e.g. travel expenses and translators)
Acceptance by authorities worldwide
Europe’s only 4-way Audit System

Your benefits

Time and money saved on audits
Independent, high-quality verifications of GMP compliance of manufacturers
Decreased workload for the qualified person
Internationally recognised API audit reports
Reduced number of audits for both Manufacturing Authorisation Holders and API suppliers

Highest quality

Our accredited third-party API audits meet the highest standards and are performed by an independent ISO 17020 (type A) accredited auditing company to ensure the highest quality and acceptance by authorities worldwide. This auditing company is Blue Inspection Body. They are accredited by the German accreditation body (Deutsche Akkreditierungsstelle). Blue Inspection Body is commercially independent of both the API supplier and the client. They will deliver the audit report regardless of the audit result.