Quality Risk Management (QRM) is a methodical approach employed to recognise, evaluate, prioritise, mitigate, and govern risks linked with product quality, safety, efficacy, and adherence to regulations throughout the product lifecycle. QRM encompasses activities such as risk identification, analysis, evaluation, control, and communication, facilitating informed decision-making and the implementation of risk-mitigation strategies. By employing QRM, organisations can proactively anticipate and address potential risks, uncertainties, and vulnerabilities, thereby safeguarding product quality, patient safety, and regulatory compliance within the pharmaceutical manufacturing realm.
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