Previous Blogs

Extractables and leachables testing

By Abigail Hisler

February 01, 2022

Drug developers must understand and mitigate the risk of various chemical entities (leachables) migrating from any material that comes into contact with their drug product. Failure to execute an appropriate extractables and leachables assessment could lead to failures in meeting agency expectations and a delay in drug development timelines.

Virtual Presenation

By Katie Casale

January 06, 2021

On November 6, 2020, West’s Regulatory Affairs Senior Director, Lynn Lundy, presented at the 2020 ISPE (International Society for Pharmaceutical Engineering) Annual Meeting and Expo. The week-long virtual meeting focused on steering the future of pharmaceutical science and manufacturing toward a more global, synchronized, and quality-driven industry. Pharmaceutical and biopharmaceutical professionals from drug manufacturing, supply chain, devices and equipment and services, and global regulatory agencies were in attendance to discuss hot topics such as Data Integrity, Covid-19 Impact, Combination Products and more.