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.
Accepting Nominations for 2017-2019 International Board of Directors
Monday, 27 Mar 2017 14.03
Data Integrity: Do You GAMP?
Friday, 24 Mar 2017 13.03
Nominate Your Facility for 2018 Facility of the Year Awards
Thursday, 23 Mar 2017 18.03