It is aligned with the quality by design concepts described by the ICH guidelines and complements the process of the development of the ICH Q14 guideline “Analytical Procedure Development and Revision of Q2(R1) Analytical Validation”.
Publishing the non-official version of the chapter beforehand should provide stakeholders with extra time to familiarize with the new requirements. It will be incorporated into USP–NF 2022, Issue 1 on 1 November 2021 and will become official on May 1, 2022.
You can access the chapter here.
USP: General Announcement
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