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VDI-EE 6306

3rd-Party GMP Audits - Supplier audits in the pharmaceutical industry

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Englischer Titel

3rd-Party-GMP-Audits - Lieferantenaudits in der Pharmaindustrie

Erscheinungsdatum
2024-03
Herausgeber
Engl. VDI-Gesellschaft Technologies of Life Sciences
Zugehörige Handbücher
Seitenanzahl
19
Erhältlich in
Deutsch
Kurzreferat

The expert recommendation is intended to be applied for auditing outsourced activities in accordance with the EU GMP Guidelines. It serves as guidance for companies and auditors, providing minimum requirements and best-practice examples for conducting and controlling GMP/GDP audits. The expert recommendation aims at standardizing and ensuring the quality of supplier audits. It outlines the preparation, execution, evaluation, and follow-up of audits conducted by third parties (raw material suppliers, packaging suppliers, contract manufacturers, and contract laboratories) and serves to determine whether the aforementioned suppliers maintain an effective quality assurance system in accordance with the applicable regulatory requirements, verify compliance with quality-related specifications from the client, establish quality assurance measures in response to objections or changes, clarify the tracking of agreed-upon measures. GMP topics can be expanded to include additional aspects from pharmaceutical law as needed.

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