Analytical procedure development: harmonization, development process as well as improvement of change management, approval and communication with authorities.
Our GMP experts are experienced in the development of analytical procedures and will advise and guide you in the preparation and your considerations for implementing all the requirements of the new ICH Q14 Guideline into practice. First, however, we will give you a brief overview of the new guideline.
In March 2022, the first draft of the ICH Q14 Guideline for Analytical Procedure Development was published. The implementation in local regulations is planned for May 2023 after conclusion of public consultation. Implementation by the European Commission will be binding for Europe and will also affect the EU GMP Guideline. Systematic approaches to the development of analytical procedures and their application principles can already be found in the ICH Q8 and ICH Q9 guidelines.
Analytical methods for evaluation of the quality of drugs as well as raw materials, starting materials and excipients are becoming increasingly important in pharmaceutical industry. Therefore, the requirements for their development must also be increasingly optimized and expanded.
Objectives of the new guideline: description of scientific and risk-based approaches for development and maintenance of analytical procedures, and specification of a minimal approach and elements of an expanded approach for analytical procedure development. Considerations for development of multivariate analytical procedures (with multiple variables) and real-time release testing are also included. In addition, principles to support change management of analytical procedures based on risk management, method understanding, and criteria for performance characteristics are outlined. The submission of analytical procedure development and life cycle information in the form of a Common Technical Document (CTD) is also dealt with.
Expected benefits of the new guideline: Harmonization of scientific approaches, key factors, and terminology for analytical procedure development in combination with an improved analytical methods understanding. In this regard, predefined performance characteristics are intended to guide development and facilitate change management of analytical procedures. Furthermore, continuous improvement shall be supported by the use of more knowledge about analytical procedures. Lastly, efforts will be reduced over the entire lifecycle of analytical procedures while providing a guideline for demonstrating suitability for real-time release testing.
Importance for the user: the draft of the guideline is in the public consultation phase and thus implementation in local regulations is still pending. Corresponding comments can now be submitted. Especially stakeholders from ICH member countries will in particular submit their comments to the respective supervisory authorities and/or the relevant ICH working groups within the set deadlines. After completion of this phase, implementation will then take place.
If you are already thinking about initial steps for the development of analytical procedures and their implementation in accordance with the new ICH Q14 guideline in your company and if you require professional support, we would be glad to support you! We advise and accompany you in all steps of the development of analytical procedures up to their implementation.
We are glad to help you so that you can implement the new ICH Q14 considerations and requirements once they are implemented!
Author: Dr. Mario Ramos Tirado, GMP Consultant, Valicare GmbH
