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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

National Institute of Health Sciences, the Ministry of Health, Labour and Welfare, Japan.

Yukio Hiyama received Ph.D. degree in 1979 in Chemistry from University of Tokyo. His current position is Chief, Third Section, Division of Drugs, NIHS, MHLW.

Responsibilities include research on pharmaceutical quality control and training of GMP inspectors. He leads an industry-government Human Science project on analytical method development for pharmaceutical development. He also leads MHLW's study groups to draft GMP related guidances and to propose the regulatory framework under the revised Pharmaceutical Affairs Law. He is a member of Pharmaceutical, Food and Sanitation Council and a co-chair of JP Chemical Monograph Committee. He has been involved in the ICH for Q8, Q9 and Q10. He is currently Q-IWG member for MHLW. His previous work experiences include scientist and director positions in Pharmaceutical Development in Upjohn Co. in US and in Japan, Visiting Associate: National Institutes of Health, Bethesda MD USA and Post-doctoral research associate: Department of Chemistry, University Illinois, Urbana IL USA.