During 2017, the USP issued a Stimuli article for a proposed new chapter, titled “The Analytical Procedure Lifecyle <1220>”, which incorporates the concept of Quality By Design (QbD) and the principles of ICH Q8-R2, Q9, and Q10 for the development and management of analytical test procedures.
There are three lifecycle phases:
- Procedure Design and Development
- Procedure Performance Qualification
- Continuous Procedure Performance Verification
A cornerstone of the design and development phase is the establishment of the Analytical Target Profile (ATP).