电邮这篇文章 Quality control management in the production of radiopharmaceuticals at the A.M. Granov Russian Scientific Centre for Radiology and Surgical Technologies
- 作者: Nepochatov I.O.1
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隶属关系:
- A.M. Granov Russian Scientific Centre for Radiology and Surgical Technologies of the Ministry of Health of the Russian Federation
- 期: 卷 3, 编号 1S (2021): Supplement
- 页面: 48-49
- 栏目: Пленарное заседание
- URL: https://medbiosci.ru/PharmForm/article/view/71775
- ID: 71775
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详细
To date, radiopharmaceutical preparations (RP) are subject to the same production and quality control requirements as non-radioactive pharmaceuticals. Although there are specific requirements for the production of RP, which complicate the fulfillment of some general requirements. For example, it is allowed to release radiopharmaceutical preparations containing some short shelf-life radionuclides for use before the completion of quality control test. This makes it difficult to work with deviations, going beyond the specification limits. There is a number of issues with validation. It is difficult to perform the Media Fill Test due to low volume production of RP. All these problems need to be addressed.
作者简介
Ilya Nepochatov
A.M. Granov Russian Scientific Centre for Radiology and Surgical Technologies of the Ministry of Health of the Russian Federation
编辑信件的主要联系方式.
Email: TO_Nepochatov@zzczst.ru
Head of Quality Assurance Department
俄罗斯联邦, 197758, Saint Petersburg, Pesochny settlement, Leningradskaya str., 70参考
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