Q2(R2): a validation framework
FDA dates its final Q2(R2) guidance to March 2024. It describes a general framework for analytical procedure validation, including principles covering the analytical use of spectroscopic data. [1]
Q14: a scientific approach to development
Q14, also dated March 2024, focuses on analytical procedure development and science- and risk-based change management. An instrument name or an isolated result is not enough to establish suitability for a particular purpose. [2]
Turn the reading into practical questions
Describe the matrix, intended use, target analyte and desired reporting format. Method suitability, validation scope and regulatory requirements depend on the specific project. This article does not imply regulatory approval or accreditation of LANHENG.