摘要
目的为药品批发企业的冷链验证提供参考。方法结合新修订《药品经营质量管理规范》(简称《规范》)实施7年来的现场检查经验,对湖北省的药品批发企业、第三方冷链验证机构开展实地考察,总结并分析湖北省药品批发企业冷链验证存在的缺陷和不足,细化和补充冷库、冷藏车、保温箱验证过程的关键点。结果与结论湖北省药品批发企业冷链验证存在企业参与度不高,自主验证率偏低,验证过程流于形式,对《规范》要求验证项目理解不透彻等问题,企业应严格遵循《规范》要求,结合企业自身实际情况实施验证,从而确保药品经营环节的质量安全。
Objective To provide a reference for cold chain verification of pharmaceutical wholesale enterprises.Methods Based on the seven years of on-site inspection experience in the implementation of the newly revised Good Supplying Practice(GSP),through the on-the-spot investigation conducted by pharmaceutical wholesale enterprises and third-party cold chain verification agencies in Hubei Province,the defects and deficiencies in the cold chain verification of Hubei pharmaceutical wholesale enterprises were summarized and analyzed,and the key points of the verification process for cold storage,refrigerated trucks and incubators had been refined and supplemented.Results and Conclusion There are some problems in the cold chain verification of pharmaceutical wholesale enterprises in Hubei Province,such as low corporate participation,low independent verification rate,mere formality in the verification process and incomplete understanding of the verification items required by the GSP.Enterprises should strictly abide by the requirements of the GSP and implement the verification based on their own actual conditions,so as to ensure the quality and safety of the pharmaceutical business links.
作者
胡晶
黄蕾
金晶
管昱州
王靓
HU Jing;HUANG Lei;JIN Jing;GUAN Yuzhou;WANG Jing(Hubei Drng Administration Center for Etaluation and Inspection,Wuhan,Hubei,China 430071)
出处
《中国药业》
CAS
2021年第20期24-27,共4页
China Pharmaceuticals
关键词
药品批发企业
湖北省
冷链验证
关键点
药品监管
pharmaceutical wholesale enterprises
Hubei Province
cold chain verification
key points
drug administration
