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.
Inaugural ISPE Biopharmaceutical Conference Opens in San Francisco
Tuesday, 06 Dec 2016 20.12
Balancing Pre- and Post-Market Control of Health Supplements
Tuesday, 06 Dec 2016 13.12
Biopharmaceutical Manufacturing Process Validation and Quality Risk Management
Monday, 05 Dec 2016 17.12