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TOP 5 GMP Downloads

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Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.


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More than 700 questions with reference to regulations for preparing and carrying out GDP audits.


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The GMP Audit Checklist works great for both sides - the auditor and the inspected company.


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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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Member of the Advisory Board and Author

John joined Pfizer in 2000 as Director, Quality Operations in Ireland. Since then he has managed the European Contract Operations Quality Assurance group and currently has quality oversight responsibility for selected Pfizer's manufacturing facilities in Europe, US, Canada and Singapore, supporting the Primary Care & Oncology Business Units.

Prior to joining Pfizer John held several positions in quality operations at Baxter Healthcare and Yves Rocher, at manufacturing site and regional level, involved in the manufacture of pharmaceutical drug products, medical devices and cosmetics. He has worked in France and Ireland.

John holds a BSc Pharm. from University College, Dublin and a Ph.D in Pharmacy from Trinity College, Dublin. He is a member of the EFPIA Manufacturing & Quality Operations Ad Hoc Group and has actively participated in EFPIA Topic Groups on ICH Q10, the European Variations Regulations and the Role of the QP.

Publications at Maas & Peither GMP Publishing:
    (Co-author of the GMP MANUAL chapter 20.D Process Analytical Technology (PAT))