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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

Max graduated from Brooklyn College of the City University of New York where he majored in Chemistry.

He retired from Hoffmann-La Roche Inc. in 2001 after 35 years of service.

From 1994 to 2001 Max was Vice President, FDA & DEA Compliance, responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals (Solid, Liquid, and Sterile), R&D, Diagnostics, Fine Chemicals and Vitamins. In that position he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals, R&D, Diagnostics, Fine Chemicals and Vitamins.

Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance. As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated this new international standard, Max is uniquely qualified to share and explain the EWG's intent of this new guidance. His involvement in this new API GMP pre-dates the ICH activity itself.

His more than 40-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees. He founded and chaired the Pharmaceutical Manufacturers Association's Bulk Pharmaceutical Committee of the Quality Control Section. Max was named Topic Leader for the Pharmaceutical Research and Manufacturers Association's (PhRMA) ICH Q7A team that developed the API GMP document for ICH. He represented USA industry at the PIC/S Canberra Conference. Max was named as PhRMA's representative on the FDA PQRI initiative that developed the initial Bulk Substance projects.

He was Vice Chair of the USP Pharmaceutical Waters Expert Committee (2000-2005) and has been re-elected to another 5-year term (2005-2010) as a member on this USP Expert committee.

For his contribution to Q7A, he was awarded the USA FDA Commissioner's Special Citation "For outstanding cooperation and achievement in developing an internationally harmonized good manufacturing practice guidance for active pharmaceutical ingredients used in human drug products."

He is a member of numerous professional organizations. He is on the Editorial Board of the Journal of GXP Compliance - and has contributed to several books dealing with APIs, and has written and published several guidances covering Bulk Pharmaceutical Chemicals (API) as chair of the PhRMA and PMA Bulk QC Committee and Workgroups.