中国标准化Issue(5)：211-215,5.DOI:10.3969/j.issn.1002-5944.2024.05.035
放射性药品质控实验室CNAS认可探索
Exploration of CNAS Accreditation for Laboratories of Radiopharmaceutical Quality Control
王定坤 1杨柳 1张云 1张文在 2熊青松3
作者信息
- 1. 原子高科股份有限公司
- 2. 中国食品药品检定研究院
- 3. 广州原子高科同位素医药有限公司
- 折叠
摘要
Abstract
In order to improve the quality control and management level of laboratories of radiopharmaceutical quality control,CNAS accreditation work has been carried out in the laboratories.The radiopharmaceutical quality control has certain particularity,the management of which not only should be in accordance with the requirements in the Good Manufacturing Practices(GMP)for laboratory,but also should consider the special nature of radiopharmaceuticals.When carrying out CNAS accreditation work,the properties of radioactive drugs such as short half-life,short period of validity,and radiation safety should be fully considered,and the two management systems should be organically integrated,combined with the actual situation of laboratories,to effectively improve the management level of laboratories.Based on the actual situation to conduct CNAS accreditation work,some key elements of CNAS accreditation for laboratories of radiopharmaceutical quality control are proposed,providing reference and assistance for production and business activities of radiopharmaceuticals in other enterprises.关键词
放射性药品/CNAS认可/质量管理体系Key words
radiopharmaceutical/CNAS accreditation/quality management system引用本文复制引用
王定坤,杨柳,张云,张文在,熊青松..放射性药品质控实验室CNAS认可探索[J].中国标准化,2024,(5):211-215,5.
