Welcome to gempex.
We are pleased about your interest.

Simply do better – reduce qualification to the essentials
And we show how it works!

Get an overview of our expertise and at the same time receive valuable tips on modern qualification. We have collected and published our GMP knowledge in numerous technical articles. You can easily request them electronically here.

Make your choice and participate in the experiences we have made.
GMP expertise from practice for practice.

The desired documents are available for download after your registration.

Expertise Qualifizierung engl

Expertise Qualifizierung Formular engl.
Do you have any technical questions on this topic? Ralf Gengenbach is at your disposal. Please leave your telephone number to make an appointment.

Please select the documents you require:

Von Experten für Experten – Qualifizierung (German language)

gempex-Kompendium mit geballtem Wissen und Erfahrung aus vielen Qualifizierungsprojekten

Qualifizierung 4.0 - Ungenutzte Potentiale (German language)

Wie eine effiziente, zeitoptimierte Qualifizierung ablaufen könnte

Zweiteiliger Beitrag von gempex, erschienen in pharmind 2017

Grundprinzipien einer effektiven und effizienten Qualifizierung – Anregungen für die Praxis (German language)

Beitragsreihe von gempex, erschienen in pharmind 01/2020 und 04/2020

Teil 1: Grundprinzipien

Teil 2: Auf die Planung kommt es an

Grundprinzipien einer effektiven und effizienten Qualifizierung – Anregungen für die Praxis (German language)

Diese Beiträge erscheinen noch in 2020.

Teil 3: Umsetzung

Teil 4: Abgleich mit den Regelwerken

ECA Guide „Integrated Qualification and Validation“, Public Draft 2

Guide for suppliers and operators,
published by a working group consisting of suppliers and pharmaceutical manufacturers

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