Q8, Q9, and Q10 Questions and Answers (R5)

Issue Date: May 29, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Quality
Status: Final

Q8, Q9, and Q10 Questions and Answers (R5)

Since the Q8, Q9, and Q10 guidances were made final, experiences implementing the guidances in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) document is intended to clarify key issues. The guidance reflects the current working procedure of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and Q10 guidances.

Download the Guidance Document

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