Facilities for national production of cold kits in Venezuela

Full text: In 1995 the Faculty of Pharmacy at the Universidad Central de Venezueal accepted the responsibility to develop radiopharmacy as a professional practice subject to corresponding sanitary regulations. The programme took into account the differents aspects that conform to the professional practice, and the Radiopharmaceutical Research and Development Center (CEIDRAF) was created under the auspices of the the Pharmaceutical Research Institute in the same faculty, that would be responsible for planning the programme. The most convenient strategy to consider each of the regarded aspects was carefully designed. Some of these aspects were identified to be: human resource capacitation, cold kits for technetiun radiopharmaceuticals production, and research and development in the radiopharmacy area. The work is focused specifically in the design of a laboratory for the national production of cold kits. It would be the first and perhaps the only one to produce this class of pharmaceuticals in Venezuela. Based on the character of the radiopharmaceuticals as parenteral drugs, facilities that conforms the cGMP design criteria for production of this class of medicaments has to be carefully considered: production laboratories provided with the necessary clean areas and well equipped to adequately accomplis the production and quality control activities. In our case, the design and building of the facilities was supported by nationals institutions, specifically, by the Universidad Central de Venezuela, and the equipment was provided mainly through the regional (ARCAL) and technical cooperation projects of the IAEA. As a result of the support, at this time we have the facilities that allows us to offer to the nuclear medicine services in our country, most of the first and second generations of cold kits for technetium radiopharmaceuticals with the pharmaceutcal quality necessary for clinical use. Our production will assure supply and accesibility of the mentioned products. In addition, we have the capacity to produce these goods in order to cover our national demand. In this poster we are showing some aspects of our facilities, such as: the layout of the clean and controlled areas, layout of equipment, design of support systems, and proposals for personnel, materials and final products. We include some pictures of the quality control laboratory as well. Additionally, the development has been complemented with a Quality Control and Assurance Programme documented in the Quality Manual elaborated according to the Venezuelan COVENIN-ISO 9001:2000 Guidelines and the Validation Master Plans elaborated according to the FDA Baseline Guide, WHO (GMP: 32th report), BPR (IAEA/ARCAL XL) and USP 27. Finally we would like to remark that this development could be taken taken as a demonstration of the impact on developing countries of adequate management of the IAEA support in all the aspects related with peaceful application of nuclear energy. (author)