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Literature review discusses quality risk management principles and applications in pharmaceuticals, suggesting improvements for safety and compliance.
Quality Risk Management (QRM) is a systematic, science-based approach for the assessment, control, communication, and review of risks affecting pharmaceutical quality and patient safety. Introduced through the International Council for Harmonisation (ICH) guideline Q9, QRM has become an essential component of pharmaceutical development, manufacturing, and regulatory compliance. This literature review discusses the principles, regulatory framework, methodologies, tools, and applications of QRM in the pharmaceutical industry. It also highlights its integration into Quality by Design (QbD), Good Manufacturing Practices Quality Risk Management (QRM) is a systematic, science-based approach for the assessment, control, communication, and review of risks affecting pharmaceutical quality and patient safety. Introduced through the International Council for Harmonisation (ICH) guideline Q9, QRM has become an essential component of pharmaceutical development, manufacturing, and regulatory compliance. This literature review discusses the principles, regulatory framework, methodologies, tools, and applications of QRM in the pharmaceutical industry. It also highlights its integration into Quality by Design (QbD), Good Manufacturing Practices
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Patil* et al. (2026) studied this question.
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