2017年山东省药品GMP认证检查缺陷项目分析

Analysis on defective items of drug GMP certification inspection for Shandong Province in 2017

目的发现2017年山东省药品生产企业在生产质量管理方面存在的共性缺陷问题,探讨药品生产企业存在的主要风险点,为企业更加规范地实施药品生产质量管理规范(GMP)提供参考。方法对2017年山东省承担的药品生产质量管理规范认证检查缺陷进行统计分析。结果与结论企业需要关注机构与人员、确认与验证、质量控制与质量保证、数据可靠性等方面存在的质量风险,有针对性地改进提升。

Objective To discover the common deficiency in production quality management existing in pharmaceutical enterprises,and analyze the existing main risk point and provide reference for implementing standard GMP.Methods Statistical analysis approached on the evaluation inspection results of pharmaceutical enterprises in Shandong Province in 2017.Results and Conclusion The company should focus on the quality risk and make improvement in institutions and personnel,validation and verification,quality control and quality assurance,data integrity.