首页> 外文期刊>Journal of Radioanalytical and Nuclear Chemistry: An International Journal Dealing with All Aspects and Applications of Nuclear Chemistry >Quality management systems in radiochemistry and radiopharmacy - applications in academy and industry
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Quality management systems in radiochemistry and radiopharmacy - applications in academy and industry

机译:放射化学和放射药学的质量管理体系-在学术界和工业中的应用

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摘要

Except the nuclear fuel reprocessing and nuclear materials safeguards, at present there are two areas of an increased responsibility of nuclear scientists for their results: radioecology and human medicaments. At both of them, quality and trustfulness of results is of great importance for their end-users and may have serious economical and legal consequences. The trends of implementation of good laboratory and manufacturing practices under umbrella of international quality management standards like ISO 17025:2005 and ISO 9001:2000 in radiochemical and radiopharmaceutical laboratories are discussed as expanding to "good scientific practice". The case studies of the Comenius University laboratory LARCHA authorized for radiochemical analysis, and the company BIONT producing medical radionuclides and PET radiopharmaceuticals are used as the examples.
机译:除了核燃料后处理和核材料保障外,目前核科学家对其结果负有越来越大的责任的两个领域是:放射生态学和人类药物。对于他们的最终用户而言,结果的质量和可信度对他们俩都很重要,并可能产生严重的经济和法律后果。讨论了在放射化学和放射性药物实验室中采用国际质量管理标准(例如ISO 17025:2005和ISO 9001:2000)的良好实验室和制造规范的趋势,这些趋势正在扩展为“良好科学规范”。此处以经科门纽斯大学实验室LARCHA授权进行放射化学分析的案例研究以及生产医用放射性核素和PET放射性药物的BIONT公司为例。

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