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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:

 

Member of the Advisory Board and Author

Pharmacist

since 1991 he has worked for the State of Schleswig-Holstein (Germany) in Drug Control, as Head of the Laboratory for Drug Analysis and later as GMP Inspector for the Regional Authorities for Health and Occupational Safety of the State of Schleswig-Holstein.

since May 2005 he has been working within the Ministry for Social Affairs, Health, Family, Youth and Senior Citizens, responsible e.g. for supervision of drug surveillance.
Member of the expert group on "Qualification/Validation" (1998-2008 head of the expert group).

He is also active in international committees, among other things as expert for the EMEA and the International Conference on Harmonization (ICH).

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of Chapters 2.A Human Resource Management, 2.B Health Monitoring and Occupational Health and Safety, 2.C Training, 3.A Official Requirements, 6.A Official requirements,,7.A Official requirements, 7.E.1 Quality by Design, 7.E.2 Process Analytical Technology (PAT), 8.A Official requirements, 14.J Batch release, 15.A Official Requirements, 17.A.8 Framework contract for contract manufacture and quality control, 18.A Principles, 18.B Inspection procedures, 18.C Inspectors, 18.D Organization of inspections, 18.F Inspection of contract manufacturers, 18.G Inspection of suppliers, 19.C Change Management)
  • Premises - PDF Download
    GMP MANUAL Chapter 3 for Download
  • GMP-Compliant Documentation - PDF Download
    GMP MANUAL Chapter 15.A for Download
  • Laboratory & Analytical Controls (PDF Download or Paperback)
  • Managing Contract Manufacturers and Testing Labs - PDF Download