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Stimuli to the Revision Process: Proposed New USP General Chapter: The Analytical Procedure Lifecycle <1220>

Type of Posting: General Announcement

Posting Date: 14–Oct–2016

Expert Committee: General Chapters—Chemical Analysis

The General Chapters—Chemical Analysis Expert Committee is currently developing a new general chapter <1220> The Analytical Procedure Lifecycle. The purpose of this new chapter will be to more fully address the entire procedure lifecycle and define concepts that may be useful.

A Stimuli article on the proposed General Chapter <1220> has been approved for publication 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 43(1). This Stimuli article provides the framework for proposed 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.

USP is providing this Stimuli article in advance of its publication to provide additional time for comments.

Should you have any questions or comments, please contact Horacio Pappa, Director, General Chapters, at 301-816-8319 or