15/16 September 2020
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]. USP is providing this Stimuli article in advance of its publication to provide additional time for comments.
In addition to offering a preview of the proposed general chapter, the General Chapters—Chemical Analysis Expert Committee and the Validation and Verification Expert Panel are seeking specific input from users in the pharmaceutical industry regarding the following questions:
The content and scope of the proposed general chapter will be refined on the basis of responses to this Stimuli article. Because stakeholders may have differing views, the objective of this Stimuli article is to identify and build areas of consensus that may be included in <1220>.
The approach is consistent with the concept of quality by design (QbD) as described in International Council for Harmonisation (ICH) Q8-R2, Q9, Q10, and Q11.
In order to provide a holistic approach to controlling an analytical procedure throughout its lifecycle, one can use a three-stage concept that is aligned with current process validation terminology:
A fundamental component of the lifecycle approach to analytical procedures is having a predefined objective that stipulates the performance requirements for the analytical procedure. These requirements are described in the analytical target profile (ATP) which can be considered as analogous to the quality target product profile (QTPP).
The Download Stimuli Article is available on the USP website since October 14, 2016: Proposed New USP General Chapter: The Analytical Procedure Lifecycle <1220>.
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 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.