PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – BANGUNAN DAN PERALATAN (UMUM) NO VERSI ASLI VERSI TERJEMAHAN 16 Radioactive products should be manufactured in controlled (environmental and radioactive) areas. All manufacturing steps should take place in self-contained facilities dedicated to radiopharmaceuticals. Produk…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PERSONALIA NO VERSI ASLI VERSI TERJEMAHAN 13 All manufacturing operations should be carried out under the responsibility of personnel with additional competence in radiation protection. Personnel involved in production, analytical control and release of radiopharmaceuticals should…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PEMASTIAN MUTU NO VERSI ASLI VERSI TERJEMAHAN 9 Quality assurance is of even greater importance in the manufacture of radiopharmaceuticals because of their particular characteristics, low volumes and in some circumstances the need to administer the…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PENDAHULUAN NO VERSI ASLI VERSI TERJEMAHAN 1 The manufacturing and handling of radiopharmaceuticals is potentially hazardous. The level of risk depends in particular upon the types of radiation, the energy of radiation and the half-lives of…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PRINSIP NO VERSI ASLI VERSI TERJEMAHAN The manufacture of radiopharmaceuticals should be undertaken in accordance with the principles of Good Manufacturing Practice for Medicinal Products Part I and II. This annex specifically addresses some of the…