药品生产质量管理规范现场检查中质量风险管理的实践分析

Practice Analysis of Quality Risk Management in Field Inspection of Drug Production Quality Management Standard

生产管理的不当是造成药品危害事件的主要原因。生产管理中所出现的一些不足之处,增加了制药企业的经济损失,既影响了企业发展,还导致用药患者的健康问题频发。由于我国人口较多,对药品的需求量更大,加强各环节质量的管理,可以减少不合格产品的出现,进而保护人们的健康,最终使药品生产管理质量得到进一步提升。药品检查员作为对药品研制、生产等场所进行合规确认和风险研判的人员,对药品的质量规范起到重要的作用。

Improper production management is the main cause of harmful events of drugs.Some inadequacies in production management have increased the economic losses of pharmaceutical enterprises.It not only affects the development of enterprises,but also leads to frequent health problems of drug patients.Because our population is larger,the demand for medicine is larger.Strengthening the quality management of all links can reduce the appearance of unqualified products,thus protecting people's health,and finally further improving the quality of drug production and management.Drug inspectors,who are responsible for compliance confirmation and risk assessment of drug development and production sites,play an important role in drug quality standards.