Conference: Analytical Procedure Life Cycle Management/Validation of Analytical Procedures –
ICH Q14/ICH Q2(R2)

Objectives

The conference will present and highlight the current developments in the field of method validation and life cycle management. Experts from industry and laboratories will present the current status of the revision and the contents of the guidelines on the one hand, and their own experiences in the establishment and validation of methods and procedures on the other hand.

Background

In March 2022 the European Medicines Agency (EMA) published the ICH guidelines Q2(R2) on validation of analytical procedures and the ICH Q14 on analytical procedure development for public consultation (Step 2b).

The previous harmonised guideline Q2(R1) has been in force in its current form since 2005. At that time, it combined the two guidelines Q2A, which contained analytical methods for required validation parameters, and Q2B, the methodology guideline. In 2018, it was decided to develop a new ICH quality guideline on analytical method development (ICH Q14) and to revise the ICH Q2(R1) guideline on analytical method validation to potentially combine both documents into one document for simplification and clarity. In parallel, the USP also developed the <1220> Analytical Procedure Life Cycle chapter, which was published in October 2021

Together, ICH Q14 and ICH Q2(R2) describe the development and validation activities proposed during the life cycle of an analytical method to assess the quality of medicinal products and medical devices:

• ICH Q14 addresses the scientific basis for the development, change management, and submission requirements of analytical methods for a minimal as well as an extended approach.
• ICH Q2(R2) provides information and specifications for establishing, submitting, and maintaining evidence that an analytical method is fit for purpose (assuring drug product quality).