Transcription of ICH Q9 ‘Quality Risk Management’ - NIHS
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ICH Q9 ‘Quality Risk Management’ - NIHS
ich q9 quality risk management -an industry viewPeter H. Gough,Eli Lilly and Company2 ContentsHow did we get here? FDA 21stCentury GMP Initiative ICH activityIntroduction to risk managementLinks between Q8, Q9 and Q10 Contents of Q9, Draft 4 ImplicationsConclusion3 FDA Pharmaceutical GMP Initiative seeks to integrate quality systems and risk managementapproaches into the existing programs and encourages adoption of modern and innovative manufacturing technology. intended to enhance theintegration of pre-approval review and cGMP programsand achieve more consistent application across agency organization components.
ICH Q9 ‘Quality Risk Management’ - an industry view Peter H. Gough, Eli Lilly and Company
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