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Contributed by dozens of experts from US, Europe and Japan. You get the best information when you need it.
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TOP 5 GMP Downloads

1. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.

 

2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.

 

3. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.

 

4. Technical Agreement
and Delimination of Pharmaceutical Responsibilities.

 

5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance

 

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Experts

You need GMP information that is reviewed by GMP experts and is guaranteed reliable. Our advisory board includes members from US, Europe and Japan. They supervise the content and development of the GMP MANUAL. More than 50 experts around the world write articles that are peer-reviewed. You get the best GMP information when you need it.

Our panel has the right background and credentials to make sure that we provide the highest level of expertise and knowledge to the industry:

 

Author

1978–1984 Study of Biology with main focus on Microbiology/University of Goettingen

1984–1987 Ph. D. thesis, Institute of Microbiology/University of Goettingen

1987–1988 University of Goettingen, Dept. of Clinical Radiation Physics and Clinical Radiation Biology:
biochemical characterization of heat shock proteins from irridated cell cultures (HeLa-, CHO-cells)

1988–1988 University of Oldenburg, Dept. of Neurobiology:
establishing a new biochemical lab, biochemical characterization of retinal proteins

1988-1989 biosyn Arzneimittel GmbH, Stuttgart:
Head of the quality control and service laboratory, biosyn Arzneimittel GmbH and G.N. Pharm Arzneimittel GmbH

1990–1944 Nordmark Arzneimittel GmbH, Uetersen:
At first head of a lab in the dept. Process Development: Isolation of heparin and enzymes from natural materials. After this head of the microbiological lab

1994–1998 Schering AG, Berlin:
Head of the Dept. Biological Quality Control

since 1999 Merck KGaA, Darmstadt:
Head of the Biological Quality Control within the pharmaceutical division

From 1995 to date, lectures on topics of microbiological quality control and hygiene, publications in journals and books;
collaboration with organizations and committees:

  • Ausschuss Mikrobiologie der Deutschen Arzneibuch-Kommission (committee for microbiology of the German Pharmacopoeia commission),
  • VfA-Unterausschuss Mikrobiologisch-technische Qualitätssicherung (VfA sub-committee for microbiological-technical quality assurance),
  • PDA member,
  • VAAM member (advisory board 2006-2009, Fachgruppe Qualitätskontrolle und Diagnostik (professional workgroup on quality control and diagnostics), vice-spokesman 2008-2010),
  • one of the founders of Curriculum Pharmaceutical Microbiology (CPM).
Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of Chapter 12.H Testing for Endotoxins)