FACILITIES FOR NATIONAL PRODUCTION OF COLD KITS INVENEZUELA

摘要

In most countries, the radiopharmaceuticals were not regarded as drugs and consequently,rntheir regulation was carried out taken in account only its radioactive nature. This means thatrnmanufacturers and distributors of these products did not have obligation to comply with requirementsrnlike Good Manufacturing Practices (GMPs). At the end of the 80′s this situation changed completelyrnas radiopharmaceuticals began to be considered as drugs. So, the production of radiopharmaceuticals,rnradioisotopes generators, and cold kits must be carried out according with the GMPs guidelines, inrnorder to assure its pharmaceutical quality. In Venezuela, the production of cold kits was considered asrna very important subject for the development of the radiopharmacy and in this regards, it was plannedrntrying to cover all the inherent sanitary aspects. This plan leaded us to design and build the adequaternlaboratory, respecting GMPs guidelines. This paper is about general aspects of this facilities; the onlyrnone in our country that produces cold kits for radiopharmaceuticals.