API audits to assess GMP compliance

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

We guarantee

Highest level of independence with Europe’s only 4-way audit system
Type A accredited audits
Highest quality
API audits by qualified auditors
Comprehensive API audit reports
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

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, independence and acceptance by authorities worldwide. This auditing company is Blue Inspection Body. They are accredited by the German accreditation body (Deutsche Akkreditierungsstelle). Diapharm coordinates the audits to be performed in a 4-way system in which the auditors are commercially independent of both the API supplier and the client. They will deliver the audit report regardless of the audit result.

Contact us for the list of audit reports available and audits in planning! >>

08/30/2019 | Eimear Schulte