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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

Stefan Köhler is a director of the Engineering department for the sterile manufacturing plant at AstraZeneca, Sweden Operations, Södertälje. This includes both common aseptic processing for freeze-dried vials and BFS technology. He started his working life as a senior-secondary schoolteacher, before becoming a technical design consultant for the pharmaceutical and process industry in Sweden in 1987. Stefan has had variety of leadership positions within technology and engineering at AstraZeneca Sweden Operations, and has extensive experience from both sterile and API production. At the start of 2000, Stefan established a new organization within AstraZeneca, focusing on clean room design and contamination control with respect to regulatory requirements and compliance. The new organization has developed a close collaboration with the Royal Institute of Technology (KTH). The collaboration has resulted in several research projects that have been published in the PDA Journal. Furthermore, he is a frequent speaker at PDA or R3-Nordic conferences.

He has spent the last 12 years in the pharmaceutical industry, specializing in the areas of sterile manufacturing, BFS Technology, Pharmaceutical utilities, Clean room design and Contamination Control. He is also a member of the PDA board since 2008.