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Regulators Led Bid To Strengthen ICH Q9 Quality Risk Management

 
• By Joanne S. Eglovitch

Inconsistency among pharmaceutical quality risk assessments drove regulatory authorities' surprise insistence on revising the ICH's 15-year-old Q9 guideline.  

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Pharmaceutical Official Tells What To Expect In ICH Q9 Revision • Source: Shutterstock

The International Council for Harmonisation (ICH) plans to revise its Q9 quality risk management guideline, which will involve a partial rewrite of certain sections rather than a wholesale revision, said a pharmaceutical industry official who was involved in the drafting of the original guideline.

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