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This paper introduces an innovative risk assessment tool, a semi-quantitative risk determination (SQRD) method designed to address risk on the operational and organizational level with a distinct patient safety perspective. Quality risk management (ICH Q9) is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. SQRD is a systematic data driven risk assessment tool. It is of practical significance to have a risk assessme

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