PDA TR 57-2

This Technical Report provides practical, risk-based guidance for the development and qualification portions of the analytical method lifecycle for biotechnology products. Method development begins with defining the requirements for the analytical method and leads to, but does not necessarily finish with, its qualification, which is a documented assessment of method performance. Guidance for analytical method development and analytical method qualification studies, such as risk-based strategies and priorities, analytical target profile and quality-by-design concepts, target performance criteria, and modern quality expectations is also included in this report.