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ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management

Yesterday (03 May, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, jointly released final guidance on "Q9(R1) Quality Risk Management".

Quality risk management (QRM) is a systematic process for the assessment, control, communication, and review of risks to the quality of medicinal products. It can be applied both proactively and retrospectively throughout the product life cycle.

The manufacture and use of a drug (medicinal) product, including its components, necessarily entail some degree of risk. By providing a proactive approach to identifying and controlling potential quality issues, an effective quality risk management approach can further ensure the quality of the drug (medicinal) product to the patient.

This document provides a systematic approach to quality risk management, and Its purpose is to guide regulators and industry professionals in making informed and consistent risk-based decisions about drug substances and products throughout their lifecycle.

Two primary principles of quality risk management are:

  • The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient.

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

Click this LINK to know more about the Risk management methodology and the Integration of QRM in the Industry & regulatory operations.


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