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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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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:

Consultant, Germany
 
 
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
 
 
 
Maas & Peither AG, Germany
 
 
F. Hoffmann-La Roche Ltd, Switzerland
 
 
Labor L+S AG, Germany
 
 
WDT eG, Germany
 
 
Hecht Technologie GmbH, Germany
 
 
Planttech Engineering GmbH, Germany
 
 
Rottendorf Pharma GmbH, Germany
 
 
GILYOS GmbH, Wuerzburg (Germany)
 
 
Consultant, USA
 
 
F. Hoffmann-La Roche Ltd, Switzerland
 
 
Halfmann Goetsch Peither AG, Switzerland
 
 
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
 
 
Ministry for Health of Land Schleswig-Holstein, Germany
 
 
Pharmaceutical Consultant, UK
 
 
former Ecolab Engineering GmbH, Germany
 
 
Basilea Pharmaceutica International Ltd., Switzerland
 
 
phaRmaK-Beratung UG, Germany
 
 
Divisional Vice President, Strategic Regulatory Affairs
 
 
Law Office Lücker MD-Law, Germany
 
 
Chair IPEC Europe Excipient Certification Committee
 
 
Clarkston Consulting, USA
 
 
Pfizer Global Manufacturing, Ireland
 
 
Pfizer Global Manufacturing, Ireland
 
 
GMP Instructor, Germany
 
 
Maas & Peither, Germany, USA; Halfmann Goetsch Peither, Switzerland, Germany, Singapore
 
 
Vetter Pharma Fertigung, Germany
 
 
Sanofi-Aventis Pharma AG, Germany
 
 
Merck KGaA, Germany
 
 
comes compliance services, Germany
 
 
F. Hoffmann-La Roche Ltd, Switzerland
 
 
ProLeiT AG, Germany
 
 
Bayer Schering Pharma AG, Germany
 
 
Consultant, Switzerland
 
 
PAREXEL Consulting, Uxbridge, Middlesex, England
 
 
Fresenius Kabi AG, Germany
 
 
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
 
 
retired since August 2005 from Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
 
 
Consultant, Germany
 
 
Process Robustness Network, Germany
 
 
GxP Services, Germany
 
 
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
 
 
Associate Director Strategic Regulatory Affairs
 
 
 
B&B Asesores, Spain
 
 
Chair of the Advisory Board
 
 
Ministry for Health of Land Schleswig-Holstein, Germany
 
 
National Institute of Health Sciences, Japan
 
 
Pharmaceutical Consultant, UK
 
 
Orion Corp., Finland
 
 
Swissmedic, Switzerland
 
 
AstraZeneca, Sweden
 
 
Basilea Pharmaceutica International Ltd., Switzerland
 
 
FDA Regulatory Compliance Consulting, USA
 
 
Maas & Peither AG, Germany
 
 
Watson Pharamceuticals Inc., USA
 
 
Bioscope Associates LLC, USA
 
 
Pfizer Global Manufacturing, Ireland
 
 
Maas & Peither, Germany, USA; Halfmann Goetsch Peither, Switzerland, Germany, Singapore
 
 
 
Health Canada