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Quality Risk Management (QRM) in the pharmaceutical industry is a systematic process of identifying, assessing, controlling, and reviewing risks to the quality of drug products across their lifecycle. It’s a crucial element of Good Manufacturing Practices (GMP), ensuring patient safety and product efficacy. QRM employs tools like FMEA and HACCP to proactively identify potential hazards in manufacturing, supply chain, and distribution. By evaluating the probability and severity of these risks, companies can implement mitigation strategies, including CAPA and revised SOPs. Effective QRM fosters data-driven decision-making, enhances communication among stakeholders, and ensures continuous improvement through regular risk reviews, ultimately safeguarding product quality and regulatory compliance.
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General
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Approval
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Introduction
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Introduction
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Introduction
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Introduction
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Introduction
Definition
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Definition
Risk Identification
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Assessment of Risk
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Assessment of Risk
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Facility system
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