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.
ISPE Member Spotlight: Dave DiProspero
Friday, 24 Feb 2017 13.02
Network with Fellow Young Professionals in Pharmaceutical Industry
Thursday, 23 Feb 2017 16.02
Share Your Expertise & Experience – Call for Speaker Proposals
Tuesday, 21 Feb 2017 19.02