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.
The Pew Charitable Trusts and ISPE Release New Joint Drug Shortages Study
Thursday, 12 Jan 2017 13.01
ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases
Wednesday, 11 Jan 2017 14.01
Chairman’s Chatter – Starting Strong in 2017
Tuesday, 10 Jan 2017 15.01