Take on ICH Q14

Robust and reliable analytical procedures are critical in the life sciences industry. In today’s complex regulatory landscape, where major treatments are developed and approved across different countries, changing an analytical procedure can be cumbersome and costly.

Global pharmaceutical companies fear facing significant delays and additional costs when an essential analytical method fails, especially for methods used to control critical quality attributes (CQA) such as purity and potency.

The adoption of ICH Q14 can help avoid these regulatory hurdles, ensuring reduced compliance risks and faster market access.