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Rainer Gnibl
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Rainer Gnibl

GMP-Inspektor der Regierung von Oberbayern.

Published articles

Two different pairs of boots: GMP for APIs and GMP for medicinal products

Two different pairs of boots: GMP for APIs and GMP for medicinal products

Some essential differences between EU GMP Guide Part I (GMP for medicinal products) and Part II (GMP for APIs) are:
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Certification of products manufactured outside the EU

Certification of products manufactured outside the EU

In the case of finished products manufactured outside the EU – in so-called third countries – the physical importation and the inextricably linked certification of the imported batch by a Qualified Person represents the final manufacturing step prior to the change of status during batch release.
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