A Quality Risk Assessment is a structured approach used within pharmaceutical manufacturing to identify, analyse, and evaluate potential risks and uncertainties related to processes, products, or systems, ensuring adherence to product quality, safety, and regulatory compliance standards. These assessments involve a thorough examination of risks, including their identification, analysis, prioritisation, and the development of mitigation strategies. By proactively managing risks throughout the product lifecycle, informed decisions can be made to minimise adverse impacts on patient safety and product quality.
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