EMA: ICH Guideline Q9 (R1) on Quality Risk Management – Step 5
On February 6th, 2023, the European Medicines Agency (EMA) published the first revision of the guideline "ICH Guideline Q9 (R1) on Quality Risk Management (QRM) Step 5".
The 27-page document includes "principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.“
These areas include development, manufacturing, distribution, and inspection and submission/review processes throughout the life cycle of APIs, drugs, biologics, and biotechnology products.
Among other changes, the revision contains additions to the following chapters of the guideline:
- Chapter 5. "Risk management methodology",
- Chapter 6. "Integration of quality risk management into industry and regulatory operations" and
- The subchapter Annex II.9 "Quality risk management as part of supply chain control".
The adopted revision will come into force by the end of July 2023.
Source:
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