von Fabienne Grieger | Jul 6, 2023 | Allgemein
Advanced in the sense of technology or in the sense of the advanced product? First things first: Advanced manufacturing is no natural relative of advanced therapy medicinal products (ATMP). There may be an epoch-making overlap of advancing technology with advancing...
von Fabienne Grieger | Mrz 8, 2023 | Allgemein
The recent FDA warning letter (recipient was DuPont Nutrition USA Inc.) has triggered a new round of discussion about GMP for Excipients. And curiously enough many of those who have commented on this issue publicly have expressed their surprise at the standards FDA...
von Fabienne Grieger | Jul 14, 2022 | Allgemein
Lesen Sie hier unseren neuen Blogbeitrag zum Thema „Annex 1 – Revolution am GMP-Himmel?“ von Wolfgang Rudloff. Der neue Annex 1 -ein Dokument, das mit so großer Spannung erwartet wurde, wie selten zuvor in der Geschichte der GMP – Regularien. Zum...
