Analytical Procedure Life Cycle Management - ICHQ14/ICH Q2(R2) This conference is part of PharmaLab Congress 2022

Zielsetzung

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.

Hintergrund

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. On 14 November 2018, a Final Concept Paper “ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation was published. It was proposed to develop a new quality guideline on Analytical Procedure Development and to revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures: Text and Methodology.

After an extended processing time, the two documents on ICH Q14 and ICH Q2(R2) were published on the 24 March for consultation by the ICH regulatory members. The goal is to finalize by Step 4 by May 2023. 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).

In summary, ICH Q14 and ICH Q2(R2) represent the harmonised scientific and technical principles for analytical methods throughout the lifecycle of analytical methods. ICH Q14, through the principles described, is intended to improve communication between industry and regulatory authorities and achieve more efficient, science-based and risk-based approval, as well as to facilitate post-approval change management of analytical methods. The revised form of ICH Q2(R2 continues to provide the general framework for validation of analytical methods, now expanded to include new technologies (e.g., for biological products or multivariate analytical methods).