International Conference on Harmonisation; guidance on Q9 Quality Risk Management; availability. Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q9 Quality Risk Management."' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The guidance is intended to enable regulators and industry to make more effective and consistent risk-based decisions.
D003226:Congresses as Topic; D003661:Decision Support Techniques; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005060:Europe; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D007564:Japan; D004364:Pharmaceutical Preparations / Q000592:standards*; D011786:Quality Control; D012308:Risk Management / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations