摘要
目的探索改进我国生物制品的监管模式。方法对比分析美国生物制品批准前检查和中国生物制品注册生产现场检查的检查依据、检查程序、检查内容及检查发现的问题,查找中国生物制品注册生产现场检查存在的问题。结果相较而言,中国生物制品注册生产现场检查程序需优化,技术标准需完善,生物制品生产企业也需加强质量体系意识。结论我国应引入基于风险管理理念开展检查的方式,建立有效的产品工艺信息和监管信息的基础数据库作为保障,敦促企业加强质量管理体系的建设,促进生物制品监管水平的提升,保障公众用药安全。
Objective To investigate the improvement of the regulatory model of biological products in China. Methods The inspection basis , procedure, inspection content and problems found in the inspection of pre-approval inspection of biological products in the United States and the on-site inspection of the registered production of biological products in China were compared and analyzed,in order to find out the existing problems in the on-site inspection of the registered production of biological products in China. Results Comparing with the PAI conducted by USFDA,the inspection procedure of the inspections on biological products in China should be optimized,the technical standards should be perfected and the quality system of biological manufacturers should be strengthened. Conclusion China should introduce the way of inspection based on the rationale of risk management,establish the basic database on effective production processes and regulatory information as the guarantee,urge the manufacturers to strengthen the establishment of quality management system,promote the development of the supervision level of biological products,and protect public safety on medicines.
作者
叶笑
曹轶
李妮
魏晶
Ye Xiao;Cao Yi;Li Ni;Wei Jing(Shenyang Pharmaceutical University,Shenyang,Liaoning,China 110016;Center for Food and Drug Inspection,China Food andDrug Administration,Beijing,China 100044;Liaoning Center for Certification of Drug,Shenyang,Liaoning,China 110036)
出处
《中国药业》
CAS
2018年第12期92-94,共3页
China Pharmaceuticals
关键词
生物制品
批准前检查
注册生产现场检查
监管模式
改进措施
biological products
pre - approval inspection
on - site inspection of the registered production
supervision mode
improvementmeasures
