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Contributed by dozens of experts from US, Europe and Japan. You get the best information when you need it.
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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

Technical and Economic Business Management (Institut für Technologie, Planung und Druck, Berlin)

1997-1998 Technical Expert Valit Consulting GmbH, Berlin
Qualification of pharmaceutical grade water systems

1998-2000 Plant Engineer Schering AG, Berlin Charlottenburg
Project head and realisation of new pharmaceutical grade water systems for the production of parenterals, preparation and execution of national and international audits (FDA), assistance in introduction of a quality system within a qualification project (documentation/equipment)

2000-2003 User representative Schering AG, Berlin Wedding
planning and construction supervision from user point of view of pharmaceutical grade water systems and technical gases of a new parenteral production plant, qualification coordinator for media supply, team head for implementation phase of the pharmaceutical grade water system, preparation of national and international audits (FDA)

since 2003 F. Hoffmann-La Roche, Switzerland

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of Chapter 5.B Generation of pharmaceutical water and Chapter 5.C Distribution and storage of pharmaceutical water (Chapters 5.C.1 Loop, 5.C.2 Fixtures and 5.C.6 Buffering of ultra pure water))
  • Pharmaceutical Water - PDF Download
    GMP MANUAL Chapter 5 for Download