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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

Grad. Eng. in Mechanical Engineering  (Technical College, Darmstadt, Germany)

Boehringer- Ingelheim, GmbH &Co KG, Biberach site
(since1982 up to the present day)

1982-1988 Energy engineer with activities in the internal power supply at the Biberach site, responsible for energy monitoring and controlling, pipe construction, infrastructure measure, centralized generation and distribution of steam and cooling media

1985-1994 Start with activities in the field of "Heating Ventilation Air Conditioning (HVAC)" for laboratories and production areas such as solid manufacture, sterile areas etc. - basic and detail engineering, realisation, execution control, start up and qualification of the air conditioning systems for new buildings and conversions, furthermore the operation with maintenance and optimisation

1995-2003 Responsible for the building services engineering for the Biberach site. In addition to the engineering, realisation and operation activities, the implementation of GMP guidelines with development and installation/validation systems for air conditioning units was in the centre of attention.

since 2003 Responsible for the group "Technical Services" with following tasks and services:
- plant engineers for research and development
- CAD-services
- Central facilities with services of the hole technical field

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of Chapter 3.G Heating Ventilation Air Conditioning (HVAC))
  • Premises - PDF Download
    GMP MANUAL Chapter 3 for Download