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WHO Draft Guidelines on Quality Risk Management: A Lifecycle Approach to Pharmaceutical Quality and Patient Safety
The World Health Organization (WHO) has issued a draft working document, QAS/26.994, titled WHO Guidelines on Quality Risk Management, dated September 2026. The draft provides recommendations for implementing quality risk management (QRM) throughout the pharmaceutical product lifecycle, covering development, manufacturing, quality control, distribution, and regulatory oversight. The proposed guidance focuses on science-based decision-making, risk assessment and control, docum

Sharan Murugan
Oct 114 min read


ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management
Yesterday (03 May, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...

Sharan Murugan
May 4, 20231 min read


ICH - Q9(R1) Quality Risk Management Draft Guidance Uupdation
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) It is commonly understood...

Sharan Murugan
Jun 18, 20222 min read
