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31 January 2011 EMA/INS/GMP[removed]Quality Risk Management (ICH Q9) The ICH Q9 document on Quality Risk Management was adopted at step 4 at the ICH Steering
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Document Date: 2012-02-16 10:45:22


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City

London / /

Company

Two / ICH Q8 Pharmaceutical / Examples / /

Country

United Kingdom / /

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Facility

Canary Wharf / /

IndustryTerm

biological and biotechnological products / pharmaceutical development / statistical tools / pharmaceuticals / pharmaceutical industry / integrated quality management / quality risk management / appropriate risk management tool / manufacturing environment / appropriate communications / risk management / manufacturing / pharmaceutical science / risk management tools / finance / materials management / healthcare professional / pharmaceutical quality / pharmaceutical assessment / pharmaceutical operations / /

Organization

American Productivity & Quality Center / European Medicines Agency / European Union / ICH Steering Committee / E-mail info@ema.europa.eu Website www.ema.europa.eu An / /

Person

Michael R. Beauregard / Raymond J. Mikulak / Robin McDermott / /

/

Position

model for quality risk management / General quality risk management process Quality risk management / General quality risk management process / /

Product

Quality / Q9 / /

PublishedMedium

the GMP Guide / /

URL

www.ema.europa.eu / /

SocialTag