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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

1989–1994 Study of Chemistry at the University of the Saarland, Germany, Degree in Chemistry

1993 Three months at the University of Surrey, Guildford, England

1994–1995 Thesis completed at the Department of pharmaceutical and Medical Chemistry in Prof R. W. Hartmann's study group

1995–1999 Doctorate in same department, scholarship from the Hermann Schlosser Foundation

2000 Awarded the Phoenix Pharmazie Wissenschaftspreis

2000–2001 MIP International Pharma Research GmbH, St. Ingbert, Germany Research consultant in the Department of Technology and Quality in the area of Galenic development/pharmaceutical technology

2001–2002 Across Barriers GmbH, Saarbrücken, Germany Researcher in the physical chemistry and analysis department

2002–2004 PHAST GmbH, Homburg, Germany Project Manager in the pharmaceutical analysis department

2005-2009 PHAST GmbH, Homburg, Germany Head of Quality Control

2009-2011 PHAST GmbH, Homburg, Germany Scientific General Manager/Head of Quality Control

2011–2013 PHAST GmbH, Homburg/flexible4science GmbH, Homburg,Germany Technical Manager and Deputy General Manager

2013–2014 PHAST GmbH, Homburg Chief Officer Process & Innovation (COPI)

From 2015 Assumption of duties in the Instillo Group

Special activities:

Seminar lectures on the following topics:

  • Method validation and transfer,
  • handling standard substances in a GMP environment,
  • optimising and increasing the efficiency of laboratory processes,
  • proper handling of OXX results,
  • error analysis in pharmaceutical analysis

Memberships:

  • Association for Pharmaceutical Technology (APV), Acting Head of Analysis and Quality Assurance group
  • German Chemical Society (GDCh)
Publications at Maas & Peither GMP Publishing:
  • GMP MANAUL
    (Author of Chapters14.H Test results outside defined criteria (OOX))