摘要
目的探讨河南省中药饮片生产企业实施新版《药品生产质量管理规范》(GMP)存在的主要问题及对策建议。方法对该省51家中药饮片生产企业55次GMP认证现场检查发现的缺陷进行统计和分析。结果与结论该省中药饮片生产企业在质量管理与质量控制、文件管理、设备管理、机构与人员、确认与验证等方面还存在不足,企业应当按照新版药品GMP标准要求,持续不断地改进质量管理体系,从而确保产品质量。
Objective To investigate the main problems in the implementation of new drug GMP on the manufacturing enterprises of Chinese herbal pieces in Henan Province, and to provide countermeasures and suggestions. Methods A statistical analysis based on 55 drug GMP inspections was conducted on all defects found in the 51 manufacturing enterprises of Chinese herbal pieces in Henan Province. Results and Conclusion There are still some deficiencies in quality assurance and quality control, documentation management, equipment management, organization and personnel, qualification and validation and other aspects, the enterprises should improve the quality management system continuously according the new drug GMP, so as to ensure the quality of products.
作者
谢芝丽
党明安
李海剑
王雯丽
Xie Zhili;Dang Ming＇an;Li Haijian;Wang Wenli(Henan Provincial Food and Drug Evaluation and Inspection Center,Zhengzhou,Henan,China 45000)
出处
《中国药业》
CAS
2018年第21期80-82,共3页
China Pharmaceuticals
