Never ever a 483?
We can not promise that you will never get a 483
but we know that the GMP MANUAL includes all
procedures and processes you need to be
GMP compliant.
Newsletter registration
PDA Parenterals Conference
From 26-28 October, 2010 the PDA Parenterals Conference will be held in Berlin.
This outstanding event will cover the very important topics:
- Future of Parenterals
- Packaging and Impact on Quality
- Manufacturing Flexibility and Control
- Innovative Plants
- Monitoring Technologies
- Medical and Application Devices
- Regulatory Trends
Don´t miss this interesting conference in Berlin, Germany.
News about GMP/cGMP
Heparin Monographs (Pharm.Eur.)
The Heparin sodium (333) and Heparin calcium (332) monographs were first revised in 2008, in the wake of serious contamination events, to allow for batch screening based on the absence of the main contaminant: over-sulphated chondroitin sulphate. Further to these emergency measures, a thorough and comprehensive review has been carried out to update and strengthen the quality standards for unfractionated heparins.
The revised heparin monographs were adopted by the European Pharmacopoeia Commission at its 136th session on 24th March using the rapid implementation procedure and are now available to download.
Outcome:
The implementation date recommended by the European Pharmacopoeia Commission is 1st August 2010; it is pending a decision by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH).
Please note that the new reference substances are not expected to be available before 1st August 2010.
Links:
EDQM/ Announcement
EDQM/ Heparin Sodium
EDQM/ Heparin Calcium