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.

Diapharm’s Global Audit Solutions Team:
Christine Brauner, Eimear Schulte, Maria Eugenia Moreno, Leon Specht

Most independent 4 way audit system

Contact us!

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