The ICH has recently published a Business Plan and a Concept Paper on the elaboration of a Q&A document on the ICH Q11 Guideline. Read more here.
ICH announces Q&A Document on Q11 Guideline – Main Focus: API Starting Materials
The ICH Q11 Guideline entitled “Development and Manufacture of Drug Substances” from May 2012 has been implemented in the three ICH regions EU, USA and Japan for 2 years now. It describes the approach to developing APIs based on an in-depth understanding of the manufacturing process and adequate strategies to control this process. The document indicates what information should be provided about the quality of the API in Module 3 of the CTD (Common Technical Document) within the framework of a marketing authorisation application.
In the meantime, there has been an accumulation of cases where the applicant and the regulatory authorities adopted different positions with regard to…
View original post 344 more words