USFDA releases ICH Q11 guidance Q&A document

ICH Q11 Q&A document specifically about starting materials

Since the ICH guidance Q11 Development and Manufacture of Drug Substances (ICH Q11) was finalized, worldwide experience with implementation of the recommendations on the development and manufacture of drug substances has given rise to requests for clarification relating to the selection and justification of starting materials.

This question-and-answer (Q&A) document is intended to provide additional clarification and to promote convergence and improve harmonization of the considerations for the selection and justification of starting materials and of the information that should be provided in marketing authorization applications and/or Master Files. The focus of the Q&A document is on chemical entity drug substances.

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