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
Üksikasjad
- Avaldamiskuupäev
- 13. oktoober 2023
- Autor
- Tervise ja toiduohutuse peadirektoraat