WHO releases updated draft guideline to strengthen quality risk management for manufacturers and regulators
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The World Health Organization has issued an updated draft guideline designed to help manufacturers establish effective quality risk management systems and to aid regulators in planning inspections.
The new guidance incorporates concepts from the International Council for Harmonisation's Q9 (R1) guideline on quality risk management.
By aligning with ICH Q9, the WHO aims to promote consistent risk-based approaches that enhance product quality and patient safety.
The draft will be open for public comment before final adoption, allowing stakeholders to provide feedback on its implementation.
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This writeup was produced by pharmadog from original reporting by raps.
Original headline: “WHO drafts updated guideline on quality risk management”
read at raps ↗
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