ICH Guidance Q14 / Q2(R2) - Analytical Method Development/Method Validation Published for Consultation

Recommendation

27/28 June 2023
Heidelberg, Germany

Dissolution Testing
Development / Quality Control and in vivo Relevance

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 - as also reported in "New ICH topic Q14 and revision of Q2" ).

In parallel, the USP also developed the <1220> Analytical Procedure Life Cycle chapter, which was published in October 2021.

Current Status

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 (in combination products).

• 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).

Table of Contents of ICH Q14

ICH Q14 contains the following sections:
 
1. Introduction (objective of the guideline)
2. Scope
3 Analytical Target Profile (ATP)
4 Knowledge and Risk Management in Analytical Procedure Development and Continual Improvement
5 Evaluation of Robustness and Parameter Ranges of Analytical Procedures
6 Analytical Procedure Control Strategy - Established Conditions for Analytical Procedures
7. Lifecycle management and post-approval changes of analytical procedures
8. Development of multivariate analytical procedures
9 Development of Analytical Procedures for Real Time Release Testing: Special Considerations
10 Submission of Analytical Procedure Related Information
11 Glossary
12.References

It also includes the following annexes

• Annex A - Analytical Procedure Lifecycle
• Measurement of Stereoisomers as Specific Process Related Impurities in a Small Molecule Drug Substance (DS) 
•  Measurement of Potency for an anti-TNF-alpha Monoclonal Antibody 
• Annex B: Validation Strategies for MODRs 
• Annex C: Example of Multivariate Model Lifecycle Components

Summary

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).

For more information, please visit the ICH website.

ECA is organising a Live Online Training Course on this important regulatory change on 5 May. Here you have the opportunity to inform yourself about the changes that will result for the validation of analytical test procedure. The speaker will be Dr. Joachim Ermer. Until recently he has been head of QC Lifecycle Management Frankfurt Chemistry, Sanofi, Germany. Here you can find the current Live Online Training on The new ICH Draft Guideline Q2 Validation of Analytical Procedures (Revision 2).