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Eudralex Volume 3 ICH Q10 Pharmaceutical quality system

Short Title:
EMA/CHMP/ICH/214732/2007
Origin/Publisher:

EMEA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel (44-20-7) 418 8400, Fay (44-20-7) 418 85 95

Document Type:
Guideline
Content:
ICH Q10 describes one comprehensive approach to an effective pharmaceutical quality system that is based on ISO concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”

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