摘要
就疫苗生产企业GMP检查时遇到的一些问题,如:在检查过程中过于注重硬件而相对轻视软件建设和执行的检查;关注产品的成品质量而对生产过程的检查相对较松;对疫苗的固有特性、生物安全、原辅材料的质量检查不严;检查员欠缺对生物制品生产和检定的专业知识等,与同行讨论商榷。
Some insufficiencies of vaccine manufacturers which were inspected during GMP spot inspection will be introduced and discussed in this essay. For instance, manufacturers pay more attention on hardware examination and comparatively less on software establishment and related performed inspection. Qualities of the final products are highly concerned whereas the inspections of production process are undemanding. Moreover, vaccine intrinsic property, biosafety issues and the qualities of both raw material and accessories are not under the satisfied strict controls. Beside of these, the inspectors lack of related background of biologic product processing and inspection is also a serious problem which will be discussed in this essay.
出处
《中国药事》
CAS
2008年第11期1022-1023,1030,共3页
Chinese Pharmaceutical Affairs
关键词
疫苗
GMP检查
产品质量
vaccine
GMP inspection
products quality
