5/6 March 2024
While in Europe the drafting or revision of ICH Guidance Q14 and Q2(R1) is at a standstill, the USP published an advance notice of its new chapter <1220> Analytical Life Cycle on 24 September. The chapter will be included in USP-NF 2022, Issue 1 on 1 November 2021, just over a year after the draft was published in September 2020, and will officially come into force on 1 May 2022.
The new chapter focuses on a holistic approach to the life cycle of an analytical procedure and the associated validation activities. It also takes into account consistency with the Quality by Design concepts as described in the ICH guidelines. As in many new regulatory guidance documents and pharmacopoeial chapters, scientific approach and sound risk management are emphasised in the development and definition as well as in the control and application of analytical methods and procedures. The "total error" principle can be applied or the measurement uncertainty can be used. The principle is applicable to all analytical procedures, whereby complexity and criticality should be the measure of effort. Relevant elements of this life cycle concept are already known from the Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics of the FDA.
Stage 1: Procedure planning covers procedure development, which consists of analytical technique and sample preparation. It includes knowledge gained through knowledge gathering, systematic process development experiments, and risk assessments and associated laboratory experiments.
Stage 2: Qualification of process performance consists of investigations to demonstrate that the process is fit for purpose. This includes confirmation that the reportable values generated by the use of the analytical procedure meet the ATP criteria and confirmation of the performance characteristics of the procedure through the traditional validation, verification or transfer studies. The data generated in stage 1 may be used if available and appropriate. At the end of stage 2, the replication strategy and the performance of the procedure are confirmed to meet the ATP and other criteria.
Stage 3: Ongoing review of the performance of the procedure involves monitoring the analytical procedure during routine use and confirming that performance continues to meet the ATP criteria. Monitoring ensures that the performance of the procedure is maintained at an acceptable level throughout the life of the procedure. It can also provide an early indication of potential performance problems or unfavourable trends and help identify necessary changes to the analytical procedure. Confirmation of process performance after modifications ensures that the modified process provides reportable values equivalent to those defined in the ATP. Further details on the life cycle of the procedure are described in the following sections.
Please note that during PharmaLab 2021, the conference track" Validation of Analytical Methods and Life Cycle Management of Analytical Procedures" will cover both the new USP chapter and the current ICH developments.