Successfully mastering inspections (GxP)

Apr 7.

A provider of therapeutic products services contacted Pharmalex GmbH as part of its periodic basic inspection. We supported them in the legal classification of the Swissmedic guidelines and technical interpretation as well as the GMP and GDP requirements of Eudralex Volume 4 of the EU and PIC/S (Pharmaceutical Inspection Co-operation Scheme). This enabled us to jointly harmonize the GMP and GDP requirements with the existing quality management system.

We advise with pragmatic solutions tailored to 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