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).  As per the draft USP <1220>, the ATP is the required quality of the reportable value produced by an analytical procedure in terms of the Target Measurement Uncertainty (TMU), where the TMU is the maximum uncertainty that can be associated with a reportable result while remaining fit for its intended purpose.

The selection of the analytical technique will consider the attributes of the material to be tested and the requirements of the ATP.  A risk assessment should be considered to understand the potential impact of the different test method variables on reported results and the necessary controls.  Design of Experiment (DOE) studies can be utilized to understand the impact of method variables on the reported result.

At the conclusion of the Design and Development stage, a report should be issued which will include how the draft procedure meets the requirement of the ATP and the required method controls for those critical test method variables.  Such a report should be a prerequisite for the performance qualification which, according to the draft USP<1220>, will confirm that the procedure generates reportable values that meet the ATP criteria (in the environment where the method will be used).

Stage 3 of the product lifecycle, Continued Procedure Performance Verification, should demonstrate that the method continues to be fit for purpose, i.e., continues to deliver against the requirements of the ATP.  This is determined through routine monitoring and the evaluation of any “changes” that could potentially impact the method, be it to the method or to the material/process that the method is supporting.

For further information and training on the topic of Analytical Procedure Lifecycle and the benefit of implementing such a program, please contact Paul Mason, Ph.D. at p.mason@LachmanConsultants.com or James Davidson, Ph.D. at j.davidson@LachmanConsultants.com.