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Quality Risk Management


According to the ICH guideline Q9 on quality risk management, the definition of Quality risk management 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.”


There are two main principles as per ICH guideline Q9;

    1. The organizations should perform and document the evaluation of the risk to quality based on scientific knowledge and ultimately link to the protection of the patient

    2. The level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk.


On the other hand, the Quality Risk Management term is mentioned in the PICS GMP Guide. It’s a systemic application of the QM policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk according to PICS GMP.

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