Successfully mastering inspections (GxP)

Apr 7.

A provider of therapeutic products regulatory services contacted us as part of its periodic basic inspection. We supported the company in the legal assessment of Swissmedic guidelines and technical interpretations, as well as the GMP and GDP requirements under Eudralex Volume 4 of the EU and PIC/S (Pharmaceutical Inspection Co-operation Scheme). This allowed us to align the applicable GMP and GDP requirements with the existing quality management system.

Our advice focuses on pragmatic solutions carefully tailored to the client’s specific needs.

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GxPGood Distribution Practice (GDP)Good Distribution Practice (GDP)Bilateral contractsGood Manufacturing Practice (GMP)Good Manufacturing Practice (GMP)Responsible person (FvP)InspectionInspectoratesTechnical interpretationRegulatory AffairsSwissmedic

Sylvia Schuepbach

Successfully mastering inspections (GxP)

Grüezi Schwiiz / Hello Switzerland

Patient leaflet and website