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 wird, wie selten zuvor in der Geschichte der GMP – Regularien. Zum...
von gmp-experts | Nov 9, 2021 | Allgemein
The Trouble with PDE Several companies have shifted their cleaning validation concept toward the use of HBEL- (Health-Based Exposure Limit), mostly PDE-based residue and carry-over limits. Basis for this is EMA guideline (EMA/CHMP/CVMP/SWP/169430/2012), commonly...
von gmp-experts | Dez 10, 2020 | Allgemein
This may take You a couple of minutes to read, but You may find it worth Your while. Just recently – during a (c)GMP-auditor training on how best to audit non-GMP suppliers, a participant asked me: „Can I not trust that when a material supplier has an...
von gmp-experts | Nov 11, 2020 | Allgemein
GMP-Audit Before You read on, please let me clarify: What I am writing here is an appeal to correct what I believe to be a defective situation in the ISO accreditation system. Yet I highly respect the effort which ISO is putting into their norms and system concepts. I...
von gmp-experts | Nov 6, 2020 | Allgemein
Die Berechnung der Prozessfähigkeit in Form des Prozessfähigkeitsindexes (Ppk bzw. Cpk) setzt die Streuung der Einzelergebnisse sowie die Lage des Mittelwerts in Bezug zu den Spezifikationsgrenzen. Je höher der Prozessfähigkeitsindex ist, desto weiter liegen die...
