ICH Q2(R2) and ICH Q14 describe mandatory requirements for the development, life cycle and validation of analytical methods.
Both ICH Q2(R2) and ICH Q14 guidelines were adopted and published by the ICH Assembly in November 2023, while implementation of the requirements began in March 2024. With the new ICH Q14, analytical methods receive guidance on the life cycle and requirements for the development of analytical methods. In addition, the revised ICH Q2(R2) adds validation and associated principles for analytical methods. Find out more about the innovations and core objectives of the two ICH guidelines here!
Analytical methods are the basis for quality control (raw material controls, release tests, in-process controls) and the later phases of research and development. The methods must be developed and validated in accordance with current legal requirements. From June 14, 2024, this must be done in the European Union in accordance with the two guidelines ICH Q2(R2) and ICH Q14, which were already implemented by the FDA in the U.S. in March 2024.
In order to comply with the state of the art in science and technology, analytical methods must be constantly optimized and efficiently developed to continuously ensure the efficacy and safety of medicinal products. The newly revised guideline ICH Q2(R2) and the new guideline ICH Q14 address these points and fundamentally define the field for the development, validation, and life cycle management of analytical methods.
Pharmaceutical filling line in the quality control department
New approaches in the development of analysis methods according to ICH Q14
The new ICH Q14 guideline will be published at the same time as the revised ICH Q2 guideline. It defines the scientific approaches for the development of analytical methods and specifies the principles for the description of the development process for these. With the exception of the multivariate experimental approach and the concept of real-time release testing (RTRT), the content of ICH Q14 is based on USP <1220 The new approaches of ICH Q14 include:
- Analytical Target Profile (ATP) as a guideline for method development and validation
- Classification of validation in the life cycle of analytical methods
- Robustness of analytical methods as a focus of method development
- Concept of in-depth process understanding
- Risk-based approach as a guideline for adapting methods to current developments and requirements
- Principles to facilitate more efficient, scientifically- and risk-based post-approval change management
The ATP is an optional document that describes the purpose of the method, the product properties to be quantified and the associated requirements for the respective product properties. The ATP thus helps to make a well-founded decision for or against the technology to be used. The acceptance criteria for the validation of analytical methods can also be derived from the ATP.
Innovations in the validation of analytical methods in accordance with ICH Q2(R2)
The most important innovations following the revision of ICH Q2(R1) are:
- The specifications of the required validation tests and parameters are described in more detail for the individual attributes
- Robustness is now part of method development
- Additions to the level of detail and changes to individual selected analytical methods in the attachments to the guideline
Conclusion
With the entry into force of ICH Guideline Q14, analytical method development in a GMP-regulated environment has been given significantly more weight in the life cycle of analytical methods. The requirements for documentation in analytical method development have been expanded accordingly.
Your analytical method, our know-how!
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Our experienced GMP experts will gladly support you with
- Implementation of ICH guidelines Q2(R2) and Q14
- Identification of GAPs
- Preparation of the required documentation
- Planning the experiments
- Interpretation of the analysis data
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Authors: Dr. Carsten Börger and Dr. Mario Ramos Tirado, GMP Consultants, Valicare GmbH
