GUIDANCE DOCUMENT
Q9(R1) Quality Risk Management June 2022
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2022-D-0705
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and Research
Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In the pharmaceutical sector, the principles and framework of ICH Q9, coupled with the official ICH training material that supports this guideline, are instrumental in enhancing the application of effective quality risk management by industry and regulators. The importance of quality systems has been recognized in the pharmaceutical industry, and it is evident that quality risk management is a valuable component of an effective quality system.
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All written comments should be identified with this document's docket number: FDA-2022-D-0705.