Stimuli article on the proposed USP General Chapter <1220> published in Pharmacopeial Forum

Recommendation

15/16 September 2020

Live Online Conference: ICH Q12 Product Life Cycle Management

A Stimuli article on the proposed General Chapter <1220> has been published in Pharmacopeial Forum 43(1) [Jan.-Feb. 2017]. Comments will be accepted until March 31, 2017, the end of the comment period for Pharmacopeial Forum (PF) 43(1).

This Stimuli article provides the framework for the proposed general chapter "The Analytical Procedure Lifecycle <1220>" and describes the current thinking of the USP Validation and Verification Expert Panel which advises the General Chapters-Chemical Analysis Expert Committee with regard to future trends in analytical procedures development, qualification, and continued monitoring.

As reported in "Now online - Stimuli article on the proposed USP General Chapter "The Analytical Procedure Lifecycle <1220>" USP has published this Stimuli article in advance of its publication in PF 43(1) to provide additional time for comments.

The USP Expert Panel would appreciate any feedback on the suggested approaches, as well as any alternative approaches for consideration.
Following your registration on the USP Pharmacopeial Forum website you can get to the proposal for general chapter <1220>.