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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.

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Author

1963-1966 Chemical Engineering School Fresenius in Wiesbaden, succesfully finished with degree Diplom-Ingenieur.

1966 Rolf started his career with Hoechst spending 13 years in Research and Production at the headquarters in Frankfurt, additional 11 years in the US where he implemented various strategies improving Quality and Efficiency in a Union environment.

1999 After joining HMR he became Director, Process Excellence of Aventis in 2000. He developed a method for measuring and improving Process Robustness, leading to a "key performance indicator". He introduced Six Sigma world wide, as the preferred method for improving Process Robustness covering API (Active Pharmaceutical Ingredients), DP (Drug Products) and Process Development.

since Jan. 2004 Rolf is a consultant assisting organizations to improve their performance via Six Sigma and Process Robustness, with the objectives to improve cash flow, reduce cost and cycle time, delight the customer and drive excellence and results in markets which are highly competitive and highly regulated.

He is a frequent invited speaker at various national and international events.

Author:

1987 "Qualitätszirkel-Handbuch für Praktiker" Fachverlag für Wirtschafts- und Steuerrecht, Schäffer Verlag, Stuttgart.

1989 "Arbeitsmappe zur Einführung von Qualitätszirkeln" , Schäffer Verlag Stuttgart.

1990 "Qualitätsorientierte Unternehmensführung, Strategie und operative Umsetzung" Schäffer Verlag Stuttgart.

1996 Co-Author: "TQM - Leitfaden für Produktions- und Verfahrenstechnik" , Springer Verlag.

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of chapter 20.B Quality Tool: Six Sigma and 20.C Statistical Process Control (SPC))