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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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anuhn@gmp-nuhn.de

Author

1982–1987 Study of process engineering/ Technical University Karlsruh

1985–1986 Study of biotechnology/ ESBS Strasbourg, France

1987 Degree thesis at the NTH in Trondheim (Norway)

1994–1996 Wedeco, Herford, project management: Planning, installation and commissioning of water treatment systems for drinking water and landfill leachates in Germany and the UK

1996–1999 Centeon, Marburg, project management: Planning and qualification of processing equipment and ancillary systems for blood plasma fractionation

1999–2003 Chemgineering GmbH, Wiesbaden, project management: Various projects for different pharmaceutical manufacturers and manufacturers of medical devices (e.g. Biotest, Ferring, Qiagen, Spimaco, Octapharm, Baxter)

2003–2005 Chemgineering GmbH, Wiesbaden, Head of Process Technology group: Various projects including establishment of Hamburg branch

2005–2007 Pharmaplan, Oberursel, Head of Department: Various projects in Germany and other countries including Portugal, India, Saudi Arabia, Sudan, Syria, South Korea, focus on aseptic processes and GMP compliance

2007–2011 Carpus Prozessexperten, Hattersheim, Authorised Signatory: Head of GMP Compliance; various projects for different pharmaceutical manufacturers including Apogepha, Bausch und Lomb, IDT, University Hospital in Munich

2011–2013 Albrecht GmbH, Langen, GMP compliance: Various projects for different pharmaceutical manufacturers and manufacturers of medical devices including Gebr. Brasseler, Ever Pharma

Since 2013 GMP Consulting Nuhn, freelance consultant: Compliance projects, FDA audit preparation, construction of a pharmacy with manufacturing authorisation in accordance with §13 AMG (German Medicinal Products Act), various training measures

Special activities

Since 1998 Presentations on cleanroom planning and operation, qualification, preparation and implementation of audits, use of isolators during the manufacture of cytostatics.
Various publications
on completed projects, zone concepts for production and laboratories, clean room planning and current GMP developments.

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of Chapter 3.E.5 Safety Cabinets)