Simplified approaches that enable changes to analytical procedures over their lifecycle are needed to allow continual improvements and adaptations due to technological obsolescence and other challenges. This article reflects on the positive impact that the recent ICH Q14 guidance can have on facilitating these changes. Five examples are provided that are based on scenarios in which analytical...
At the 2024 ISPE Annual Meeting & Expo, held 13-16 October in Orlando, Florida, USA Nina Cauchon, PhD, Director, Regulatory Affairs -- CMC, Amgen, led a session on the global adoption status and implementation strategies for recent International Council on Harmonization (ICH) guidelines
Pharmaceutical and biotechnology companies employ platform analytical procedures in the development stages of their synthetic and biological drug products and are beginning to leverage them for commercial products. This shift is supported by the acceptance of platform procedures in the recently adopted ICH Q2(R2) and ICH Q14. Six case studies are shared in this article to highlight how...
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has recently announced the adoption of the revised guideline
