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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.

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Author

Dr. Bernd Renger is currently Vice President Quality Control at Vetter Pharma Fertigung in Ravensburg, Germany.
He holds a degree and a Ph.D. in Organic Chemistry from the University in Gießen, Germany.

1976 In 1976 he started his professional career with Hoechst AG as a R&D Chemist.

1984 After leaving Hoechst in 1984 he has held several management positions in Quality Control and/or Quality Assurance at Mundipharma (Limburg), Byk Gulden (later Altana Pharma, Singen) and Baxter BioScience (Vienna) before joining Vetter in 2004.

He is member of the Advisory Board of the European Compliance Academy and Chairman of the European Qualified Person Association, an organisation representing more than 1.300 Qualified Persons in Europe.

His main fields of interest are benchmarking and efficacy of quality operations, handling of deviations and OOS results, Quality Systems and role and responsibilities of the Qualified Person.

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of chapter 19.A Quality Assurance Duties, 19.B The "Qualified Person" according to Directive 2001/83/EC and 19.D Corrective and Preventice Actions(CAPA))