The desire for a dramatic increase in process understanding over
the past eight years has left industry leaders and Global Health
Agencies searching for a more relevant model for developing process and
drug substance understanding. Most recently, the Internationa l Conference on
Harmonization (ICH) has been drafting the ICH guideline q11 on the development and manufacture of drug substances, which takes a considerable step forward, offering sponsors greater flexibility in the definition and selection of Regulatory Starting Materials (RSM).
http://www.triphasepharmasolutions.com/Regulatory%20API%20Starting%20Materials%20Article.pdf
