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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.

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

Pharmacist (University of Wuerzburg, Germany)

1996-2000 School of Pharmacy (University of Wuerzburg)

2001-2002 Scientist, Pharmacology Department (University of Erlangen)

2003–2006 PhD thesis and graduation in Pharmaceutical Technology (University of Wuerzburg)

2006-2007 Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach (Germany) Post-Doc:
Project: Nanoization of poorly soluble compounds

2007-2010 Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach (Germany) Pharmaceutical Development:
early and late stage drug product development (NDA and life cycle projects, highly potent compounds), compilation and review of submission documents, Continuous Process Improvement (Six Sigma)

Since 2011 GILYOS GmbH, Wuerzburg (Germany) CEO:
freeze-drying process design and optimization, physicochemical characterization of materials (freeze-dry microscopy), assessment of the morphology of freeze-dried products (specific surface area, scanning electron microscopy), technical consulting for freeze-drying equipment, operational qualification and performance testing

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of chapter 12.F Freeze-drying)