ICH Q9 Quality Risk Management has been updated and the current version is effective from 26/07/2023 It provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products.
mp_ich_q9guideline-ra_en.pdf
Details
- Publication date
- 13 October 2023
- Author
- Directorate-General for Health and Food Safety