摘要
随着《中国药典》2020年版的实施,中药材、中药饮片需按照药典标准对重金属含量和农药残留量进行检验,药品生产企业因社会分工的细化及降低成本将这些检验项目委托给第三方检验机构进行检验,这种情况成为行业内的普遍情况。目前的药品法规应对新形势下药品委托检验的监管存在不足,持有人或生产企业履行主体责任的意识不强,政府的外部监管力:度需要加强,第三方检验机构自身的检验能力和声誉需要提升。要加强药品委托检验的管理,需要持有人、生产企业、监管部门和第三方检验机构共同努力,履行各自职责,以推动药品委托检验的规范和发展。
With the implementation of"Chinese Pharmacopoeia"2020 edition,due to cost reduction,some inspection items are entrusted to a third-party inspection agency by the marketing authorization holder or the manufacture of medicine.The current medicine laws still have defects in the supervision of medicine entrusted inspection.The awareness of the subject performing the responsibility is not strong,the external supervision of the government needs to be strengthened,and the inspection ability and reputation of the third-party inspection institutions themselves also have problems.To strengthen the management of entrusted drug inspection,the holders,manufacturers,regulatory authorities and third-party inspection institutions need to work together to perform their respective responsibilities,so as to promote the standardization and development of entrusted drug inspection.
作者
詹西里
詹绮华
Zhan Xili;Zhan Qihua(Guilin Sanjin Pharmaceutical Co.,Ltd.,Guilin,Guangxi 541199,China)
出处
《首都食品与医药》
2023年第18期14-16,共3页
Capital Food Medicine
关键词
药品委托检验
第三方检验机构
药品检验机构:药品生产质量管理规范
Commissioned inspection of medicine
Third-party inspection agency
Inspection agency of medicine
Good Manufacturing Practice of Medical Products
