USP<1220> and ICHQ14 are among the most discussed topics today in the analytical industry. With the evolution of compliance and work-flow understanding, the need to incorporate Quality by Design (QbD) principals in analytical methods has been long realised. Analytical life cycle management is the holistic approach of implementing structured QbD approaches in the analytical workflow (also segmented as stages I-II-III). To better understand this concept, we can consider the evolution of the wheel as an example. No doubts that initially when the wheel was invented, it was a great invention. It was a paradigm shift in the movement of goods/ loads from one location to another. But, initially, wheels were made of stone, they were very heavyweight and that added to lesser efficiency or more force was required to pull. Later physicians designed wheels with wooden frame (to reduce weight) and the outer circumference was covered with a metal ring (to provide strength). In modern times, scientists worked on improving efficiency and created modern-day metal frames with rubber tyres. But, is it the end of this evolution? Definitely NO! Several researchers are continuously working on newer technologies to improve it further.
In a similar context, when I look at pharma products, evolution/ adoption of newer technologies is not so fast and easy. Considering its possible implications on human health, a detailed assessment is made mandatory by regulatory authorities. But this has made industry follow some old technologies/approaches that gives repeated failures, and (in some cases), even limits detection of poor-quality products. Recent recommendations from USP and ICH are in the direction of providing a structured approach for the design and development of these analytical strategies that support the development of analytical methods with better control on variabilities. In simple words, we can say that the method lifecycle approach is preventive approach to control method variables and understand method parameters space better.
Lifecycle management approach brings a shift from the current segmented approach towards a holistic approach. In the current workflow, the analytical development team develops methods and gains understanding of the impact of variables on method performance in a very limited space/ scope. Also, another missing portion is the transfer of this knowledge space to subsequent stages. Due to an unstructured development approach, many variables are not properly assessed. Later, validation as per USP<1225> is completed and a final method protocol goes (Analytical procedure transfer USP<1224>) for next stage (i.e. QC lab) for routine usage (Analytical Procedure verification USP<1226>). Now with proposed USP<1220> all these stages (Development, Validation and Routine monitoring/ usage) will be covered under single chapter/ section.
To understand this upcoming transformation in analytical methods handling, I would try to answer rationales of 'What', 'Why' and 'How' for analytical method life cycle approach.
What is the analytical method life cycle approach?
As defined in USP<1220>; the current concepts of validation, verification and transfer of procedure address portions of the lifecycle but do not consider it holistically. The purpose of the proposed new chapter <1220> is to fully address the entire procedure lifecycle. The approach is based on Quality by Design concepts as described in the International Council on Harmonization Q8 (R2), Q9, Q10 and Q11. The lifecycle management process provides a framework for defining the criteria for and development of an analytical procedure that meets the acceptance criteria. The procedure then becomes part of a continuous verification cycle to demonstrate that it meets the predefined criteria over the life of the analytical procedure.
Analytical method lifecycle is a science-based risk management approach to develop a robust analytical method by identifying the impact of critical assay parameters and controlling variability by the implementation of control strategy’.
Why is the adoption of analytical method life cycle important?
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