Comment from CMC Regulatory Services, LLC
AnonymousOtherIndividual
Summary: The commenter is seeking clarification on where specific development work regarding drug substance characteristics and impurities will be located in the new M4Q(R2) draft. They also request more concrete information on the content of each subsection compared to the current guidance.
1. Where in the new M4Q(R2) draft will the development work currently captured in 3.2.S.3 be summarized and detailed? This work is fundamental to the process of determining accurate CQAs and justification for proposed controls over drug substance and drug product impurities. Yet the elucidation of D.S. characteristics doesn't appear to be addressed.
2. What is the rationale for providing very little concrete information about the content of each subsection, compared to the current M4Q(R) Guidance. Are we to assume that this concrete guidance should in all cases be aligned with the ICH Q Guidances? Only in some cases is that specified.