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...
von gmp-experts | Okt 7, 2020 | Allgemein
What makes a GMP-Compliant `Quality Culture´? Promoting and fostering an adequate Quality Culture is a GMP-Requirement. The European Medicines Agency (EMA) requires this to assure data integrity, and so do WHO and PIC/S. And it does not matter whether GMP-inspectors...
