Implementation of a Metrology Programme to provide traceability for Radionuclides Activity measurements in the CNEN Radiopharmaceuticals Producers Centers

• Autor(a) principal: Andrade, Érica
• Data de Publicação: 2013
• Outros Autores: Braghirolli, Ana Maria Silveira, Instituto de Engenharia Nuclear
• Tipo de documento: Artigo de conferência
• Idioma: eng
• Título da fonte: Repositório Institucional do IEN
• Texto Completo: http://carpedien.ien.gov.br:8080/handle/ien/2399
• topic: INAC 2013; Nuclear medicine; Radiopharmaceutical; Radionuclides; Metrology Programme

The commercialization and use of radiopharmaceuticals in Brazil are regulated by Agência Nacional de Vigilância Sanitária (ANVISA) which require Good Manufacturing Practices (GMP)certification for Radiopharmaceuticals Producer Centers. Quality Assurance Program should implement the GMP standards to ensure radiopharmaceuticals have requirements quality to proving its efficiency. Several aspects should be controlled within the Quality Assurance Programs, and one of them is the traceability of the Radionuclides Activity Measurement in radiopharmaceuticals doses. The quality assurance of activity measurements is fundamental to maintain both the efficiency of the nuclear medicine procedures and patient and exposed occupationally individuals safety. The radiation doses received by patients, during the nuclear medicine procedures, is estimated according to administered radiopharmaceuticals quantity. Therefore it is very important either the activity measurements performed in radiopharmaceuticals producer centers (RPC) as the measurements performed in nuclear medicine services are traceable to national standards. This paper aims to present an implementation program to provide trace ability to radionuclides activity measurements performed in the dose calibrators (well type ionization chambers) used in Radiopharmaceuticals Producer Center placed in different states in Brazil. The proposed program is based on the principles of GMP and ISO 17025 standards. According to dose calibrator performance, the RPC will be able to provide consistent, safe and effective radioactivity measurement to the nuclear medicine services.