USP publishes draft of new chapter <1220> Analytical Procedure Life Cycle

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

Already in 2016 the development of a new USP chapter entitled "The Analytical Procedure Lifecycle" was announced. The aim should be to demonstrate the suitability of an analytical method over the entire life cycle, i.e. including design, development, validation and continuous verification. The previous concepts of validation, verification and method transfer of the USP deals with parts of the life cycle, but do not consider it holistically. Therefore it was suggested to deal with the whole life cycle in a more comprehensive way and to define helpful concepts in a general USP chapter.

At the beginning of 2017 a first "Stimuli" article on the proposed USP General Chapter was published with the title "The Analytical Procedure Lifecycle <1220>". At that time a three-stage concept was proposed:

• Stage 1: Procedure Design and Development (knowledge gathering, risk assessment, analytical control strategy, preparation for qualification) 
• Stage  2: Procedure Performance Qualification 
• Stage 3: Continued Procedure Performance Verification (routine monitoring, modification of an analytical procedure)

In terms of content, the approaches went in the same direction as the QbD concept, which is described by the International Council for Harmonisation (ICH) in the Guidelines Q8-- Q12.

Now in the current Pharmacopoeial Forum, PF 46 (5) the first draft of USP <1220> Analytical Procedure Life Cycle has been published. It continues to follow the principle of 3 steps with the main focus on the ATP (Analytical Target Profile). The draft states that ATP is an essential part of the life cycle approach. The ATP serves as a prospective description of the desired performance of an analytical method used to measure a quality characteristic and is defined, for example, in quantitative or semi-quantitative methods, among other things, by the requirements for precision and accuracy. The ATP thus focuses on the design objectives for a new analytical method and serves as a basis for validation and monitoring of the method during its life cycle.

There are parallel activities on ICH level e.g. with the draft of the guideline ICH Q14 Analytical Procedure Lifecycle Management, the revision of ICH Q2 (R1) Analytical Validation and the new ICH Q12 Guideline Product Lifecycle Management. The draft can be viewed after registration for the Pharmacopoeial Forum.

During the Live-Online Conference "ICH Q2/Q14 - Analytical Procedure Life Cycle Management - from development to continued verification" international experts and members of the respective ICH and USP working groups for the new chapters and guidelines will present the latest developments.