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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:

 

Author

1990–1992 Certified Technician specialising in electrical engineering

2003–2006 Business English, University of Cambridge

1992–1998 Uhlmann Pac-Systeme, Laupheim, Germany, Electrical Design:
Development, programming and design of system controllers for packaging machinery (B&R, Eberle, Elau and Siemens S7).

1998–2006 Uhlmann Pac-Systeme, Laupheim, Germany, Head of Validation:
Establishment and management of the Validation services department for the entire blister packaging division with a total of 10 employees. Implementation of large projects worldwide. Contact for customer audits, especially in the area of GxP and CSV. Implementation of 21 CFR Part 11 analyses.

2006–2009 ServoTech GmbH, Head of Sales and Marketing for pharmaceutical services:
Establishment and integration of the sales organisation in the company. Management of international trade fairs such as Interphex New York, Interphex Singapore, Achema Frankfurt, Interpack, etc.

since 2009 testo industrial services, Head of Sales Southeast & East
Establishment of the Southern Sales branch (Blaubeuren), implementation of GxP workshops, Management of CSV projects.

2011 Publications in Pharma Food, Pharmind Editio Cantor Verlag, Aulendorf, Germany

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of chapter 4.D System controllers and process control systems, 13.C Qualification of a servo-controlled blister packaging line, 3.J.6 Validation of a monitoring system in
    accordance with GAMP5©)