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Contributed by dozens of experts from US, Europe and Japan. You get the best information when you need it.
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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

1983–1987 Study of Pharmacy at „Freie Universität Berlin”

1987–1992 Graduate degree at Ph.D. level in pharmaceutical technology granted by “Westfälische Wilhelms-Universität Münster”

1992–2006 Schering AG Berlin (Germany):

1992 Research and Development: Development and improvement of ultrasonic contrast media and their manufacturing process

1993–1995 Assistant to the head of production: Development and implementation of computer and cleaning validation concepts and their corresponding internal regulations

1995–1997 Deputy to the head of production responsible for a solids plant manufacturing highly potent hormonal products

1998–1999 Personal assistant to a member of the Schering AG Board responsible for production, environmental protection, personnel and North America

1999–2001 Head of a parenteral plant at the Berlin Charlottenburg site; head of production since 2000

2001–2005 Head of a new established parenteral plant for contrast media at the Berlin Wedding site

2005–2006 Head of Global Counterfeit Protection Management: Establishing the function, development and implementation of processes related to the fight against counterfeit medicines (worldwide scope)

since 2006 Bayer Pharma AG, Berlin (Germany):

Head of Counterfeit Protection Management: Further development of the topic and integration of the function and processes into the organizational and regulatory structure of Bayer HealthCare Pharmaceuticals (worldwide scope)

Special Activities

since 1993 Numerous presentations in course of trainings and conferences related to the topics of: computer validation, cleaning validation, concepts to fight counterfeit medicines, efpia’s European verification system proposal based on a 2D data matrix code and the German pilot-project securPharm

engaged in further education courses for pharmacists concerning the fight against counterfeit medicines

2006–2007 Schering AG Membership at the Pharmaceutical Security Institute (PSI)

2006–2012 Active member of the efpia Anti-Counterfeiting Working Group

since 2010 Technical Advisor to the Board of the Pharmaceutical Security Institute (PSI)

since 2011 Member of the DIN/CEN standards working groups dealing with tamper verification devices compliant with the EU Falsified Medicines Directive

Publications at Maas & Peither GMP-Publishing:
  • GMP MANUAL
    (Author of Chapter 19.I Fight against counterfeit medicines)