by 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...
by 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...
by 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...
by 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...
by gmp-experts | Jul 9, 2020 | Allgemein
The EU GMP Guide does not mention Quality Oversight or QA-Oversight anywhere. But this does not mean that the EU GMP system does not provide adequate mechanisms to attain to the task. But first let´s go one step back to see where this whole topic even came from…...
by gmp-experts | Jun 22, 2020 | Allgemein
Nachweis der Prozessstabilität In den Leitlinien zur Prozessvalidierung der EU sowie der FDA wird gefordert, dass die Stabilität von Herstellprozessen nachgewiesen werden muss. Wie kann dies erreicht werden? Ein einfacher und zugleich effektiver Weg Ihre Daten...
