BRFAA - Biomedical Research Foundation Academy Of Athens
Biomedical Research Foundation Academy Of AthensAcademy Of Athens

ISO 17025


Accreditation of the Laboratory of Pharmacology - Pharmacotechnology according to the ISO 17025 standard

The laboratory of Pharmacology - Pharmacotechnology of BRFAA, after an effort that lasted for more than two years, was recently (October 2008) accredited by the Hellenic Accreditation System S.A. (E.SY.D) according to the standard "ΕΛΟΤ ΕΝ ISO/IEC 17025:2005" for the analysis of the peptide drug Leuprolide in human plasma. Given the existing experience and infrastructures, the laboratory, which also operates according to Good Laboratory Practice (GLPs) guidelines, is now able to expand its Certificate of Accreditation for the quantitative measurement of any drug in biological fluids and tissues.

For the realization of this goal, our laboratory begun a collaboration with the company "Priority Quality Consultants", in February of 2007, towards the development of a quality system according to the standards of ISO 17025:2005. Funding for this effort became available from a Grant «ΑΚΜΩΝ» issued by the Greek General Secretariat for Research and Technology (Principal Investigator: Dr. P. Sideras, Co-Investigators: Dr. C. Tamvakopoulos and Dr. A. Andreakos).

For the purposes of the ISO, the laboratory was organized as follows: Head of Scientific Affairs: Dr. C. Tamvakopoulos, Quality Assurance Manager: A. Gaitanis, M.Sc., Analysts: C. Tamvakopoulos, Ph.D., A. Siskos, Ph.D., Z. D. Sofianos, M.Sc., T. Katsila, M.Sc. Dr. Tamvakopoulos with extensive experience in bioanalytical and in pharmacokinetic/bioavailability studies, has assumed the responsibility that the laboratory will follow the ISO standards and will produce results of high integrity. Mr. A. Gaitanis (Head of Sector of Biomedical Technology-BRFAA) was selected and trained accordingly for the position of Quality Assurance Manager and with his additional experience is now able to consult and collaborate with other laboratories of BRFAA on quality management issues. All members of the laboratory have been trained extensively on issues regarding the application and philosophy of the ISO standard and in topics relative to drug bioanalysis using Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS).

The preparation of our laboratory for the accreditation was achieved in 8 stages, lasting 6 months in total: 1/ Diagnostic study, 2/ Initial training, 3/ Development of quality management system and organizational structure, 4/ Development of Standard Operational Procedures (S.O.P.s), 5/ Quality handbook, 6/ Training on the quality system, 7/ Testing of the quality system and 8/ Application Submission to the Hellenic Accreditation System S.A. The standard operating procedures we developed in the context of the preparation for the application included SOPs related to the evaluation of our suppliers and the receipt of consumables, to safety and hygiene, to the validation of analytical methods, to the assessment of uncertainty in measurements, and to the use, service and repair of scientific instrumentation. The Quality Management System is kept electronically using specifically designed software (e-Qual) which is consistent with the requirement of the ISO Standard for automatic registration of corrective actions and updates of existing protocols and procedures. Finally, all the laboratory equipment that is critical for the analysis (analytical balance, pipettes, solvent evaporation system, freezers, deep-freezers, thermometers etc.) has been certified by external experts or by our own division of Biomedical Technology).

The application was submitted to E.SY.D. in July 2007. In November 2007 a pre-assessment was carried out by E.SY.D. inspectors that determined that the laboratory met the requirements of the ISO Standard and was allowed to proceed to the final audit/inspection, which took place in April of 2008. The Certificate of Accreditation was granted in October of 2008.

I would like to congratulate all members of the team that worked hard towards this important accomplishment and I would also want to thank BRFAA's management for supporting our efforts. I strongly believe that through the capability given to us by this ISO Accreditation, the laboratory of Pharmacology will contribute significantly to the development of novel or generic drugs.

Dr. C. Tamvakopoulos
Head of Scientific Affairs

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Download ISO Accreditation Certificate for Pharmacology - Pharmacotechnology Division