FDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances” in the Nov. 20, 2012 edition of the Federal Register. The guidance was prepared under the auspices of the International Conference on Harmonization (ICH) and describes approaches to developing and understanding the manufacturing process of a drug substance, as well as providing 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) to enable a consistent approach for providing and evaluating this information in the European Union, Japan, and the US.
According to the announcement, the final guidance contains revisions to the introduction and process development sections of the draft version of the guidance to more strongly emphasize that purification processes play a significant role in drug substance manufacture. The final guidance also incorporates revisions to the discussion of design space for chemical entities and biotechnological/biological drug substances, and revisions to the discussion of control strategy.