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13.12.2024

ICH: Updated Q9(R1) Annex 1 – Q8/Q9/Q10 Questions & Answers

The ICH has published the updated Q9(R1) Annex 1: Q8/Q9/Q10 Questions & Answers (R5) related to ICH Q9(R1) Quality Risk Management (QRM).

The Q&As have been updated by removing outdated text and rephrasing the Q&As considered in view of the implementation of ICH Q8, Q9 and Q10, with minor additions to address minor content gaps in the document. Furthermore, minor edits have been made to improve the readability of the document.

Sources:

ICH: News

ICH: ICH Q9(R1) Annex 1: Q8/Q9/Q10 Questions & Answers (R5)

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