Petra Rempe, PhD

Petra Rempe works in the GMP/GDP inspectorate of the district government in Münster, Germany. After initially being responsible for the GMP supervision of manufacturing sites, her area of responsibility expanded with the increasing legal requirements and now also includes plants that have to work according to Good Distribution Practice (GDP) or the principles of good practice according to the EU Tissue Directive.

Petra Rempe is a (founding) member of the inspectors‘ expert group EFG 10 "Qualification/Validation", which she also headed for many years.

After studying pharmacy and obtaining a PhD in pharmaceutical technology, Petra Rempe worked in the pharmaceutical industry for several years. Her focus was particularly on the production of non-sterile dosage forms, most recently as head of production. In addition to these activities, she was involved in projects such as building reconstruction, qualification/validation and product transfer within the EU.

During her industrial activity Petra Rempe was also a member of the pharmaceutical-technological committee of the German Medicines Manufacturers´ Association (BAH), working group "Validation/Qualification".

After moving to the District Government of Münster, she has been working as a GMP/GDP inspector since 1998. She remains closely connected to the topic of qualification/validation through her work in the EFG 10.

Petra Rempe regularly communicates her specialist knowledge in events and lectures. She has been supporting the GMP-Verlag Peither AG since 2007.

She is author or co-author of the following chapter of GMP Compliance Adviser:

19.A Agency expectations of quality risk management

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