Accreditation of the Laboratory of Radiopharmacy – requested requirements or need of challenge

  • Katarina Delipetreva Faculty of Medical Sciences, Goce Delcev University – Štip
  • Paulina Apostolova Faculty of Medical Sciences, Goce Delcev University – Štip
  • Katarina Smilkov Faculty of Medical Sciences, Goce Delcev University – Štip
  • Darinka Gjorgieva Ackova Faculty of Medical Sciences, Goce Delcev University – Štip
  • Marija Sterjova Faculty of Medical Sciences, Goce Delcev University – Štip
  • Emilija Janevik Ivanovska Faculty of Medical Sciences, Goce Delcev University – Štip



Laboratory of Radiopharmacy is a part the Faculty of Medical Sciences, Department of Pharmacy in the Goce Delcev University in Stip and was granted by the Government of Republic of Macedonia as a part of the project for improvement of the laboratories in the country. The main field in which the Laboratory of Radiopharmacy has focused after the establishment in 2011 is to introduce a new molecules as a potential radiofarmaceuticals, labeling with radioactive and not radioactive isotopes, defining their structure and especially chemical and radiochemical identification of potential impurities. In the same timecarefully implementing radiation safety program for controlling laboratory environment. The Laboratory is deeply involved in the educational program in all cycles of academic degrees following a few international and local research projects. The laboratory staff is educated and trained in the national and international programs in the field of Radiopharmacy and Radiochemistry, as well included in the training coursesdedicated to the implementation the standards and quality assurance providing additional effectivenessin the work.

All that activities including the requested requirements from the Ministry of Education and Sciences were enough strong reason to start the process of accreditation of the Laboratory of Radiopharmacy and to focus on that all our activities in the next period. The aim of our study is to introduce, to validate and to accreditate the procedures for quality control of radiopharmaceuticals for clinical and research purpose according regulatory standards. At that stage we have in progress the process of Accreditation with implementation of Standard MKC EN ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories. International Standard ISO/IEC 17025 specifies the general requirements for the competence of testing and calibration laboratories if they wish to demonstrate that they operate a quality system, are technically competent and are able to generate technically and scientifically valid results. The compliance these requirements enables the acceptance of testing and calibration results also between laboratories and countries.

Our Laboratory of Radiopharmacy currently is in the phase of implementation of the General requirements for the competence of testing and calibration laboratories of the Standard MKC EN ISO/IEC 17025. This standard holds five clauses, two annexes, and one bibliography section, out of which, the most important are Clause 4, that specifies the management requirements, and Clause 5, that specifies the requirements for technical competence for the type of tests the laboratory undertakes.

In the same time we are preparing the first method that will be applied to as ISO recognized. The process of accreditationis a longprocess of implementation of the standards and require continuous engagement of all staff and persons included in whole activities of the Laboratory.

After the establishment in the current location and have sufficient and competent staff that was necessary required we started with the initiative of accreditation. We are expecting that the implementation of ISO/IEC 17025 as part of laboratory quality initiatives will provide both, recognized laboratory in a medical and clinical application including professional benefits, and have important rule in the research and educational field, have an access to more agreements for testingand improvednational and global reputation. In the same time constantly to expand data quality and laboratory effectiveness. This will also permit to reach the agreement of thetrends of implementation good laboratory under umbrella of international standards like ISO 17025 in radiopharmaceutical and radiochemical laboratoriesexplained as a need of expandingof “good scientific practice”.

The accreditation process of the laboratories according Standard MKC EN ISO/IEC 17025 is also applied for Radiopharmacy and Radiochemistry. We are expecting that our Laboratory of Radiopharmacy will finish the first step of accreditation until June 2016 and be able to continue on the same road of good recognized work following already accepted standards and to have full access and confidentiality to the national and international research and clinical activities.


Key words: Accreditation, Laboratory of Radiopharmacy, MKC EN ISO/IEC 17025.