中国食品药品监管Issue(6)：70-75,6.DOI:10.3969/j.issn.1673-5390.2025.06.009
原料血浆质量控制与血液制品污染控制策略研究
Study on the Control Strategy of Raw Plasma Quality and Blood Product Contamination
摘要
Abstract
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.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Key words
raw plasma/blood products/contamination control strategy/quality control/sterile preparations分类
医药卫生引用本文复制引用
麻银林,贺学锋,勾洋梅,孔丽亚,胡闽,山琳..原料血浆质量控制与血液制品污染控制策略研究[J].中国食品药品监管,2025,(6):70-75,6.基金项目
甘肃省药品监督管理局药品监管科学研究项目(2023GSMPA018) （2023GSMPA018）
