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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

Pharmacist (University Erlangen, Germany),  Dr. rer. nat. in Pharmaceutical Technology  (University Marburg, Germany)

1987-1989 3M Medica/ Kettelhack-Riker, Borken (Germany)
Project Management in galenical development; development of an oral Drug Delivery System made of pellets containing starch with an enzyme-controlled active ingredient release; preparation of clinical trial samples

1989-1994 Sandoz Pharma AG, Basel (Switzerland)
Pharmaceutical Development, Drug Delivery Systems Dept., head of laboratory for the development of nasal and pulmonary dosage forms with systemic effect

1994-1997
Sandoz Pharma AG, Basel
Technical R & D - Quality Assurance Unit as assistent to the head of department, establishment of  a quality unit which reflects the special needs of R&D, compilation of a quality manual for pharmaceutical development

1997-2010 Novartis Pharma AG
Quality Assurance Unit Technical R&D and Biotech Development and Production, Part-time in Quality Systems and GMP Training, freelance work in GMP Training, emphasis on process validation

2002-2004 Study of "Teaching, Learning, Leading" at PH Freiburg

since 2011 GMP Instructor

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Co-author of Chapters 6.E.1 Examples of IQ plans and 6.F.1 Examples of OQ plans)
    (Author of Chapters 7 Process Validation (chapter 7.B Validation - a key element of quality assurance to chapter 7.E Validation protocol and report), 16 Research and Development and 18.H Questionnaire for preparing GMP-inspections)
  • Documenting Process Validation - PDF Download
    A Drugmaker's Guide
  • Checklist GMP-Inspections