FDA Guidance on ICH Q9(R1) Quality Risk Management

3 May 2023 – the FDA published final guidance on the ICH Q9(R1) quality risk management.

The purpose of this document is to offer a systematic approach to quality risk management that leads to better, more informed, and timely decisions. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk- based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle.

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