ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities), Step 3 was released for public comment on 16 June 2011. This guideline describes approaches to developing process and drug substance understanding, and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 – 3.2.S.2.6. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8 R2), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) as they pertain to the development and manufacture of drug substances. ICH guideline Q11 on development and manufacture of drug substances.
Meet 2016 – 2017 ISPE International Board of Directors
Wednesday, 24 Aug 2016 19.08
Biotechnology Manufacturing – Transforming Healthcare for Millions
Tuesday, 23 Aug 2016 13.08
Future of Pharma Product Development & Production Systems
Monday, 22 Aug 2016 13.08