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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

1989 University degree in Pharmacy

1990-1995 Doctorate in Pharmaceutical Technology
(University of Saarland, Germany)

1995-1997
Fresenius AG (Bad Homburg, Germany), Production of large volume parenterals: Assistant of head of manufacturing, different projects dealing with GMP upgrade and productivity improvement

1998 Fresenius AG (Friedberg, Germany): Production of large volume parenterals:
Head of different manufacturing lines, deputy head of manufacturing for complete production facility according to German Drug Law

1998-2006 Pharmaplan GmbH (Bad Homburg, Germany):
Consulting activity for pharmaceutical industry with regards to qualification, validation, GMP-Compliance
Project manager for many national and international projects

2004
Head of department Qualification, Validation and GMP-Compliance

2007-2008 Fresenius Kabi AG (Bad Homburg, Germany) Corporate Quality Management:
Director QS-Systems and Compliance. Qualified Person third party manufacturing for Fresenius Kabi Germany

since 2008 Fresenius Kabi AG (Bad Homburg, BU Compounding):
Director Technologies and QM Compounding.

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of chapter 3.F Building services and chapter 3.H Process Gases)
  • Premises - PDF Download
    GMP MANUAL Chapter 3 for Download