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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

1977–1986 Study of Chemestry and Genetics/ University of Cologne

1986–1991 Boehringer Mannheim, Penzberg (Germany), Group Leader in Chemical Laboratories and Quality Control:
development and implementation of quality control methods for recombinant therapeutics proteins, reaching national and FDA compliance

1991–2012 Biotest AG Dreieich (Germany), Head of Global Quality Asuurance:
Implementing quality assurance and quality management systems for pharmaceutical products, in vitro diagnostic and medical devices for the mother company and its affiliates; regulatory basis were the German, European and FDA regulations

2013–today Freelance Consultant:
performing audits all over the world, running national and international seminars, performing in-house training and supporting companies to reach the regulatory complience

Cooperation with national and international consultancies

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of chapter 19.H Complaints and Product Recalls)