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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:

 

Member of the Advisory Board and Author

Lothar obtained his Diploma and Ph.D. in Technical Chemistry/Biotechnology from the Technical University of Berlin.

He joined Hoffmann-La Roche in 1988 and served in numerous functions in the global Quality Department. Lothar acted as “Head of External Relations”, interacting with regulatory health authorities and associations for more than a decade before being assigned as “Head of Knowledge Management”. He is now Head of Quality at Crucell Switzerland AG a Johnson & Johnson company.

He served for approximately 10 years on the board of APIC/CEFIC as Vice-Chairman. In this function he was nominated for the ICH Q7a Expert Working Group setting up world-wide harmonized GMPs for APIs. In this effort he also was FDA awarded in May 2004. Lothar is co- and lead-author of various documents published by CEFIC/APIC and EBE (European Biopharmaceutical Enterprises).

Lothar served as member in the “Board of Directors” of PDA (Parenteral Drug Association) and as chair of EBE's BioManufacturing Working Group. He is an expert in GMPs for APIs and ATMPs, Pharmaceutical Quality Systems and Knowledge Management.

Publications at Maas & Peither GMP Publishing