USFDA announced implementation of the ICH Q9(R1) guideline Quality Risk Management. Earlier ICH had adopted the Revision 1 guideline in Jan 2023 (draft was already circulated in Nov 2021) (see presentation) . ICH Q9(R1) address four areas of application – Formality (formal documentation of QRM), Subjectivity of QRM, Risk based decision making & Supply chain and product availability risks. Risk Identification terminology is changed as Hazard identification (Future QRM activities should reflect this change) to fully realise the benefits of QRM Read More..