湖北省注射剂类药品生产质量管理规范认证实施现状分析

Current Situation and Analysis of Implementation of Good Manufacturing Practices Certification for Injection Drugs in Hubei Province

目的为省级药品监管部门实施注射剂类药品生产质量管理规范(GMP)认证提供参考。方法汇总湖北省通过药品GMP认证的10家注射剂类高风险药品生产企业产品质量相关的基本情况,并分析相关问题。结果企业产品自检合格率由认证工作下放前的95.50%提升至下放后的99.98%,管理质量稳步提升,但在注册工艺变更、企业技术人员储备和检查员培训方面还有待进一步提升。结论药品GMP认证检查工作下放成功,建议进一步缩短注册工艺变更的审批时间,加强对企业和地方局检查员的培训和指导。

Objective To provide a reference for provincial drug regulatory departments to implement Good Manufacturing Practices(GMP)certification for injection drugs.Methods The basic situation of product quality of 10 high-risk injection drugs enterprises in Hubei province which had passed GMP certification was summarized,and the related problems were analyzed.Results The qualified rate of self-inspection of enterprise products increased from 95.50%before the decentralization of certification to 99.98%after the decentralization.The quality of management has been steadily improved,but there was still space for further improvement in registration process change,enterprise technical personnel reserve and inspector training.Conclusion The decentralization of drugs GMP certification and inspection is successful,it is suggested that the examination and approval time of registration process changes should be further shortened and the training and guidance for enterprises and inspectors of local bureaus be strengthened.