Understanding USP<1220>

Kuldeep Sharma, Product Manager- Waters (India) explains what, why and how of the method lifecycle approach

- Kuldeep Sharma

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.