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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

1988-1994 Doctorate in Pharmaceutical Technology
(University of Saarland, Germany, Prof. Dr. Loth)

1994-1997 Gödecke AG (Germany), Quality Assurance: cleaning validation (development and implementation of an FDA compliant validation concept for a newly built manufacturing plant for solid forms, FDA Audit 1996), qualification (production equipment, laboratory equipment, media), change control, audit, cooperation with consultants

1997-2000 Gödecke AG (Freiburg, Germany) Process Technology:
Product transfers, Scale up and validation of manufacturing processes, Process optimization, Scale up and validation of NDA products; FDA pre-approval inspection 1999

2000-2005 Pfizer GmbH Arzneimittelwerk Gödecke (Freiburg, Germany), Quality Management: Project work during maternity leave, e.g. update of master plans, translation of policies, preparation of annual product reviews

2005-2008 Pfizer GmbH Arzneimittelwerk Gödecke (Freiburg, Germany), Technical Services: Process optimization, Raw material qualification; international Co-Development, Risk Management, Scale up and validation of NDA products, Quality by Design, Right First Time, Six Sigma Projects; FDA pre-approval inspection 2007

since 2008 Maas & Peither AG GMP Publishing, editorial department

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of  chapters 8.B How to validate cleaning procedures, 8.C Cleaning validation master plan, 8.D Establishing the scope of validation, 8.E Acceptance criteria and limit calculation, 8.G Analytical procedures, 8.H Documentation, 8.I Maintenance of the validated status, 8.J Cleaning validation documentation (example))