The Regulatory Affairs Perspective:Addressing Compliance for a Changing Industry

摘要

Bioprocessing remains a highly regulated industry, and full compliance is vital to ensuring the high quality, safety, and efficacy of biopharmaceuticals. Working collaboratively with the FDA early in a process can help manufacturers meet comprehensiveregulatory expectations and address regulatory concerns when working with new technologies or therapeutic classes. Over the past 15 years, regulatory agencies have released or revised many industry guidances and requirements. Most of them have come about because of increased in process knowledge, improvements in the precision of laboratory instruments and methods, and the need for flexible process systems.