摘要
随着生物医药技术的迅速发展,血液制品的安全性日益受到社会广泛关注。血浆作为血液制品生产的原料,其质量直接关乎最终产品的安全性与有效性。当前,原料血浆质量控制及血液制品污染控制策略亟待进一步优化,以切实提升血液制品的安全性。本研究系统分析了原料血浆在采集、检验和储存等过程中存在的质量控制问题,并对现行血液制品污染控制策略的有效性进行了评估。此外,还通过对某血液制品生产企业及其19个单采血浆站有关资料进行分析,提出了更加精确、有效的血液制品污染控制策略。在综合考虑各环节风险的基础上,本研究构建了从源头到最终产品的全链条污染控制体系,旨在为血液制品生产企业的原料血浆管理和血液制品污染控制提供参考,同时为相关行业标准的修订以及血液制品生产监管提供借鉴。
With the rapid development of biopharmaceutical technology,the safety of blood products has received increasing attention.At present,the quality control of raw plasma and contamination control strategies for blood products require further optimization to improve product safety.This study systematically analyzes quality control issues during the collection,testing,and storage of raw plasma,and evaluates the effectiveness of existing contamination control strategies for blood products.Based on data from a blood product enterprise and its 19 plasma collection stations,this study proposes more accurate and effective contamination control strategies.A full-chain contamination control system,from source to final product,is constructed to provide valuable references for raw plasma management,contamination control in blood product manufacturing,revision of industry standards,and regulatory oversight.
作者
麻银林
贺学锋
勾洋梅
孔丽亚
胡闽
山琳
MA Yin-lin;HE Xue-feng;GOU Yang-mei;KONG Li-ya;HU Min;SHAN Lin(Gansu Provincial Drug Administration Review and Inspection Center(Gansu Provincial Vaccine Inspection Center);Lanzhou Biological Pharmaceutical Co.,Ltd.)
出处
《中国食品药品监管》
2025年第6期70-75,共6页
China Food & Drug Administration Magazine
基金
甘肃省药品监督管理局药品监管科学研究项目(2023GSMPA018)。
关键词
原料血浆
血液制品
污染控制策略
质量控制
无菌制剂
raw plasma
blood products
contamination control strategy
quality control
sterile preparations
