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EDQM announces renewal of its ISO 9001 :2008 Certification

and the extension of its scope to pharmacopoeial activities

(11/01/13) The certification was awarded by Afnor Certification (AFAQ) in December 2012. To register as ISO 9001:2008 compliant, the EDQM underwent a stringent evaluation process that included its quality management system, a full documentation review and staff training and competence management.


Human and Veterinary OCABR Guidelines

(10/12/12) Two new webpages have been created under our "Publications, Products and Services" section to present respectively Guidelines for the VBRN veterinary batch release network and the EU Official Control Authority Batch Release for Human Biological Medicines. The Guidelines are now available only on the EDQM website, which contains the most up-to-date versions. On each page a table now contains the Preface and notes for use, OCABR administrative procedures, General information, Product Specific Guidelines and Model Protocol Templates. You will also find information on the recent updates of guidelines.


OMCL Counterfeit Training, 4-5 Oct 2012, Warsaw

(12/11/12) The first tailor-made hands-on training for OMCLs on the testing of counterfeit and illegal medicines took place from 4 to 5 October 2012 at the premises of the National Medicines Institute in Warsaw, Poland and was co-organised by the Polish OMCL and the EDQM. Twenty trainees from 17 Member States followed the course which consisted of a general introductory part and five practical parallel sessions in small groups where the following techniques were introduced:

  • LC (Liquid Chromatography) -MS/MS (Tandem Mass Spectrometry)
  • LC (Liquid Chromatography) - CAD (Charged Aerosol Detector)
  • Psychoactive plant identification
  • XRPD – X-ray Powder Diffraction
  • NMR - Nuclear Magnetic Resonance Spectroscopy.

The training gave the participants the opportunity to follow the testing of authentic samples of falsified medicines in the laboratory itself and to exchange experience with peers about the sampling preparation, test performance and interpretation of test results.


Canada becomes an observer to the EU OCABR Network

(25/07/12) The EDQM, on behalf of the EU Official Control Authority Batch Release (OCABR) Network, has signed a memorandum of understanding (MoU) with the Biologics and Genetic Therapies Directorate (BGTD) of Health Canada. The MoU, in force as of 27 July 2012, will see the participation of Health Canada in numerous OCABR network activities in the field of vaccines for human use and medicines derived from human blood and plasma.
Read the Press Release on Canada's new status as observer to the EU OCABR Network

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