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- W4298032112 abstract "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." @default.
- W4298032112 created "2022-10-01" @default.
- W4298032112 date "2006-06-02" @default.
- W4298032112 modified "2023-09-29" @default.
- W4298032112 title "International Conference on Harmonisation; guidance on Q9 Quality Risk Management; availability. Notice." @default.
- W4298032112 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/16795933" @default.
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