An Excipient Warning Letter: Many were surprised. But why?
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...
Annex 1 – Revolution am GMP-Himmel?
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 einen deshalb, dass...
PDE-Based Cleaning Limits: Best Practice or Deficiency?
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...
GMP-Auditing an ISO-Company: Eight (8) Basic Pointers.
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 ISO-xxx...
GMP-Auditing ISO-Certified Suppliers: Many Faces – Same Conclusion?
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...
Sinnvolle Grenzwerte für die Prozessfähigkeit
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...
Quality Culture
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...
EU GMP and Quality Oversight: How does it work?
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......
Prozessstabilität
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...
GDP: Transportation of Medicinal Products
Kategorie: GDP -Taking a Shot at Interpreting the ´Temperature´ Issue- Quality management requirements for transportation (EU) of Drug Products are mainly laid down in the Good Distribution Practice Guidance for Medicinal Products for Human Use Chapter 9...