The scope of Quality Control department (QCD) of the Hellenic Pasteur Institute is to assure that pharmaceutical products conform to specifications in line with current pharmaceutical legislation.
Ιτ is an independent unit and is divided into three deferent quality testing laboratories:
The HPI-QCD applies the current European Pharmacopoeia, as well as is in line with the current pharmaceutical legislation.
Quality control operates on behalf of E.O.F. (National Drug Organization) to third parties and pharmaceutical companies. The HPI-QCD has licensed authority by the Institute of Pharmaceutical Research and Technology (I.F.E.T) to perform controls on vaccines and biological products. The Q.C. department also participates in research programs for the development of new products for diagnostics.
The laboratory was certified, by ISO-9002 until 2003 by the TUV CERT Certification Body of Reinich-Wetfalischer, now is certified with current GMP (18469/ in conjunction with decision on extension of Controls on Imported Human and Veterinary Medicines) and has accreditation ISO 17025: 2005(516-3).
Since 1995, tests have been carried out for the immunological response of vaccines. Up to now, 6,000 serum have been tested, mainly for protective antibodies to Tetanus, Diphtheria, and Bordetella. The Department is also a Member of Hellas Lab and Eurolab (European network of Control Laboratories). Also controls the 70% of the vaccines moved by the Public Sector.