FDA Adopts Final Version of Q11 Guidance - - BioPharm International

ADVERTISEMENT

FDA Adopts Final Version of Q11 Guidance



FDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances” in the Nov. 20, 2011 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.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

NIH Seeks to Improve Vaccine Response with New Adjuvants
September 30, 2014
Baxter International Plans to Open R&D Center for Baxalta
September 30, 2014
FDA Releases First-Ever Purple Book for Biosimilar Characterization
September 26, 2014
FDA and NIH Win Award for IP Licensing of Meningitis Vaccine
September 26, 2014
FDA Releases REMS Report
September 25, 2014
Author Guidelines

Click here