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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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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

1994–2000 School of pharmacy (Ernst-Moritz-Arndt University, Greifswald and Heinrich Heine University, Düsseldorf )

2005–2010 PhD thesis and graduation in Pharmaceutical History (University of Technology, Braunschweig)

2000–2001 Hospital Pharmacist

2001–2007 Wiewelhove GmbH, quality control:
pharmacist in the quality control department, afterwards deputy of head of quality control, then head of quality control and Qualified Person

2007–2009 Haupt Pharma GmbH, quality control:
deputy of head of quality control and Qualified Person

2010–2012 Wiewelhove GmbH:
Qualified Person and assistance of quality management representative

since 2013 DS Pharma GmbH:
head of regulatory affairs

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of chapter 19.F Batch Record Review)