New ICH guideline Q14 on Analytical Procedure Development

In January 2024, the European Medicines Agency (EMA) published the ICH Q14 guideline as Step 5. The date for coming into effect is 14 June 2024.

The ICH Q14 Guideline outlines science and risk-based methods for developing and maintaining analytical procedures for assessing drug substance and product quality. Moreover, it aligns with principles from ICH Q8 (Pharmaceutical Development) and Q9 (Quality Risk Management), advocating for a systematic approach and risk management. The guideline distinguishes between minimal (also known as traditional) and enhanced approaches to analytical procedure development, with the latter offering a more comprehensive understanding and control strategy. And while the minimal approach remains an acceptable approach to development of a robust analytical procedure that is fit for the intended purpose, some or all elements of the enhanced approach might be used to support development and lifecycle management of analytical procedures. 

The scope of this guideline covers procedures for release and stability testing, applicable to commercial products and clinical development. Regarding the minimal approach, it involves identifying product attributes, selecting appropriate technology, conducting performance studies and documenting the procedure. In contrast, the enhanced approach also includes risk assessment, experiments and defining a control strategy. This emphasizes understanding procedure parameters and allows for greater flexibility in lifecycle management. 

Furthermore, the guideline also outlines the analytical procedure lifecycle, detailing development, change management and validation, with flexibility in the sequence and extent of each element.

If you’re developing an analytical method and would like some guidance with respect to this new ICH Q14 guideline, feel free to contact us.