In the actual operation process of pharmaceutical wholesale enterprises,the return and disposal of unqualified drugs challenge the drug quality management system and compliance requirements of the enterprises.By analyzing the classification of the unqualified drugs,the causes of and the regulatory requirements of the unqualified drugs,this paper puts forward corresponding suggestions on the return and disposal of the unqualified drugs in different situations,so as to minimize the potential risks of drugs in the circulation process,improve the quality management efficiency of the drug wholesale enterprises,and promote the high-quality and healthy development of the pharmaceutical circulation industry.
关键词
药品批发企业/不合格药品/药品退货及处置/合规要求
Key words
drug wholesale enterprise/unqualified drug/return and disposal of medicine/compliance requirement