吡拉西坦片仿制药一致性评价的生产现场检查

On-site Inspection of Consistency Evaluation of Piracetam Tablets

目的:为正在开展仿制药一致性评价企业更加规范地实施提供参考。方法:对吡拉西坦片一致性评价现场检查的基本流程、迎检准备及检查应对等实例进行梳理、总结。结果:通过吡拉西坦片一致性评价现场检查流程及内容介绍,明确了仿制药一致性评价现场检查企业工作侧重点。结论:企业应该重点关注质量保证体系、数据完整性、与申报资料一致性等方面,有针对性从这些方面加强控制和管理。

Objective:Through the basic process,preparation and response of on-site inspection for consistency evaluation of piracetam tablets,this paper provides reference for enterprises that are carrying out consistency evaluation of generic drugs to implement it more standardized.Methods:Combing and summarizing the on-site inspection of consistency evaluation of piracetam tablets.Results:Through the introduction of the field inspection process and content of piracetam tablet consistency evaluation,the focus of generic drug consistency evaluation field enterprises was clarified.Conclusion:Enterprises should focus on the quality assurance system,data integrity,consistency with the application materials,etc.,and should strengthen control and management from these aspects in a targeted manner.