API Audits to Ensure GMP Compliance
Diapharm ensures cost-efficient auditing of manufacturers of pharmaceutical active ingredients, starting materials, and packaging manufacturers. Diapharm collaborates with a Type A ISO 17020 accredited inspection body for active ingredient and excipient audits, guaranteeing the highest level of impartiality and independence in all audits.
These audits provide high-quality, independent review of manufacturers' GMP compliance. Obtaining third-party API audit reports allows pharmaceutical companies to save time and costs compared to conducting their own audits.
Diapharm manages the entire audit process, from preparation to CAPA plan follow-up. Our service includes drafting and signing confidentiality agreements and quality agreements, supplying all necessary audit documentation, the auditor’s CV, and a declaration of absence of conflicts of interest.
Independence and Acceptance
The client commissions an audit with Diapharm.
Diapharm engages blue inspection GmbH to conduct the audit. Preparation, documentation, and project management are handled by Diapharm.
Auditors from Organization:2 conduct the audit at the respective manufacturer (API, excipient, packaging material). blue inspection GmbH is accredited according to ISO 17020 for conducting audits of active ingredient and excipient manufacturers.
The manufacturer is audited by an auditor from blue inspection GmbH.
The independent audit report is prepared by the auditor. Diapharm monitors CAPA follow-up and provides the report to the client.
Execution of API Audits by an Accredited Service Provider
To ensure the highest quality, independence and worldwide recognition by authorities, the API audits are carried out by an independent audit service provider accredited according to ISO 17020 (Type A) – blue inspection body GmbH, accredited by the German Accreditation Body (DAkkS).
Diapharm coordinates audits within the 4-Way Audit System, ensuring that the auditors act commercially independent of both the API manufacturer and the client.
For an overview of all audit reports and audit planning, please contact us!
