Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
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) . 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
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