News about GMP/cGMP

15.10.2021

USP: General Chapter 1220 of Analytical Procedure Life Cycle pre-published

USP: General Chapter 1220 of Analytical Procedure Life Cycle pre-published

The United States Pharmacopeia has released a new Chapter 1220 on “Analytical Procedure Life Cycle” prior to its official publication and entering into force on 1 May 2022. The chapter considers the validation activities that take place across the entire life cycle of an analytical procedure and provides a framework for the implementation of the life cycle approach.


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.


Source:

USP: General Announcement


 

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