Tulina M A, Pyatigorskaya N V
Institute of Pharmacy and Translational Medicine, I. M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation, Moscow, Russia.
Bull Exp Biol Med. 2018 Mar;164(4):579-582. doi: 10.1007/s10517-018-4035-8. Epub 2018 Mar 4.
The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.
本文描述了生物医学细胞产品（BMCP）的良好生产规范（GMP）的特殊方面，这意味着在整个生产过程中要有高标准的无菌操作，对供体和生物材料分离程序有严格要求，保证BMCP产品的可追溯性，定义允许将BMCP识别为最低限度操作的加工程序；在生产的所有阶段进行持续质量控制和控制过程的自动化，这将确保在技术操作完成的同时产品放行。
