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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

1983–1988 Study of Chemical and Process Engineering; Technical University of Karlsruhe,Germany

1988–1993 Technical University of Karlsruhe, Germany, Department of Food Process Engineering: Research Assistant/teaching and research activities

1993 Doctorate in Chemical and Process Engineering; Technical University of Karlsruhe,Germany

1994–1997 Gödecke AG, Freiburg, Germany/ Process Development and Optimisation: Product transfers, scale-up and validation of manufacturing processes in a newly built solids factory; qualification of equipment; processing of investment projects; qualification of raw materials; process optimisation

1997–2009 Fresenius Kabi Deutschland GmbH/ Enteral Nutrition Division, Engineering: Expansion and maintenance of own production; support of contract manufacturers; optimisation of manufacturing processes and production facilities; standardisation in Production and Engineering; environmental protection and industrial safety certifications

2009–2012 Fresenius Kabi Deutschland GmbH/ Global Operations – Clinical Nutrition & Complex Formulations, Technical Development: Technical responsibility for manufacturing processes; technical consulting; optimisation of manufacturing processes and production facilities; planning and layout of new buildings and production expansions; supervision of production processes outsourced to subcontractors

Since 2012 Holopack Verpackungstechnik GmbH, Germany Head of Production (GMP production)/Operations:Ensuring GMP-compliant manufacturing; production and process standardisation; process optimisation; FDA audits 2012,2014

Special activities:

Since 1987 Member of the Association of German Engineers (VDI)

Since 1995 Lectures on different aspects of pharmaceutical production methods and packaging, especially in plastic packaging

Publications at Maas & Peither GMP Publishing:
  • GMP MANAUL
    (Author of Chapter 13.D Blow-fill-seal technology (BFS technology))