Can I read Q11 Q&as Step4 Presentation on EtoBox?

Q11 Q&as Step4 Presentation by xingyuan2517 is a document available to read on EtoBox.

What is Q11 Q&as Step4 Presentation about?

The ICH Q11 document provides guidance on the selection and justification of starting materials for drug substances, addressing issues related to regulatory acceptance and manufacturing processes. It emphasizes the need for clarity in definitions and the importance of considering all principles outlined in Q11 when selecting starting materials. The document underwent public consultation and revisions to improve comprehension and ensure alignment with regulatory expectations.

Author

xingyuan2517

Language

EN