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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.

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

Process and Environment Engineer, Berlin Technical College

1990-1997 Schering AG Berlin: Plant Engineer in microbiological development Charlottenburg, main focus fermentation technology

1997-1998 Schering AG Berlin: Plant Engineer in pharmaceutical production Charlottenburg (manufacture of liquids), main focus on water treatment plants - generation, storage and distribution of GE water and wfi water

since 1998 Schering AG Berlin: Head of group for technical supervision of 2 production units, maintenance of function, optimization and further development of technical plants for the production of echo contrast agents and micronization of active ingredients under GMP conditions.

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Auhthor of chapter 5.D Qualification of water supplies and chapters 5.E.2 Maintenance of a water supply to 5.E.6 Decommissioning/uninstalling)
  • Pharmaceutical Water - PDF Download
    GMP MANUAL Chapter 5 for Download