Podcast Host Gabrielle Bejarano talked to Chris White, who is the Global Head of GMP at Adamas Consulting, about what’s new and different in Annex 1, and how sterile manufacturing companies and facilities can meet the regulations by the summer of 2023.

In pharmaceutical manufacturing, the presence of endotoxin poses a risk to final product quality and patient safety. This article will discuss what endotoxins are, how they can be detected, and how you can prevent contamination.

On August 25th 2022, the FDA alongside EMA jointly released its new Annex 1 regulations for sterile drug manufacturing processes, monitoring, quality control, and more. The revision has been 14 years in the making, and largely overhauls the original 2008 good manufacturing practices with the aim of reflecting the changes of evolving manufacturing processes. The new regulations take effect on August…

After several years of delays, the EU and FDA are now doubling down on their efforts to force drug manufacturers to comply with Annex 1…