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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

Study of mechanical engineering and and promotion in chemical engineering at the Swiss Federal Institute of Technology ETH, Zürich/Switzerland

20 years in industrial HVAC and cleanroom design and contracting
research and development
department manager in overseas subsidiary
group director for technology

since 1991 independent consultant in contamination control and quality risk management.

1987-1994 President of the Swiss Society for Contamination Control, and subsequently, 1994-2004 executive manager

1988-1990 Chairman of the International Confederation of Contamination Control Societies.

1990-2004 Swiss representative in the standard committees ISO/TC 209 and CEN/TC 243 Cleanroom technology

1973 - today speaker, moderator and workshop leader at many conferences in Europe, the Americas, the Near East and East Asia

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of chapter 3.C Room classes, chapter 3.E Barrier systems and isolators, chapter 3.I Qualification of premises and air-conditioning systems and chapter 3.J Monitoring of HVAC systems)
  • Premises - PDF Download
    GMP MANUAL Chapter 3 for Download