摘要
目的为药品上市许可持有人制度下的供应商质量审计提出建议与对策。方法结合药品行业供应链现状,对物料和物料供应商进行风险分析,提出相应的质量审计对策。结果在我国开始试行药品上市许可持有人制度的现状下,明确了上市许可持有人与合同生产企业开展对物料供应商质量审计的主要事项。结论药品上市许可持有人应根据自身能力,以风险管理为原则,采取有效措施对供应商进行质量审计。
Objective To put forward suggestions and countermeasures for the quality audit of suppliers under the system of marketing authorization holder.Methods According to the current status of the supply chain in the pharmaceutical industry,risk analysis was carried out on material and material suppliers,and corresponding quality audit countermeasures were put forward.Results Under the current situation of marketing authorization holder system in China,the main issues of quality audit of material supplier for marketing authorization holder and contract manufacturer were clarified.Conclusion Marketing authorization holder should take effective measures to do quality audit of suppliers according to their ability and the risk management principle.
作者
翟铁伟
ZHAI Tiewei(Center for Food and Drug Inspection of NMPA,Beijing,China 100044)
出处
《中国药业》
CAS
2019年第19期10-13,共4页
China Pharmaceuticals
关键词
药品上市许可持有人
供应商
质量审计
药品监管
marketing authorization holder
suppliers
quality audit
drug administration
