The Food and Drug Administration (FDA) posted a guidance entitled “Q11 Development and Manufacture of Drug Substances.” 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 describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities). The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products.
FDA Guidance for Industry - Q11 Development and Manufacture of Drug Substances (PDF)
ICH Q11 - Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological Biological Entities) (this links navigates to a page containing Q11-related documents)
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