摘要
目的调查我国药用辅料使用与管理的现状及存在问题,提出意见及建议,为生产监管、认证、检查提供参考。方法对我国七省市辖区内不同规模、生产不同制剂类型的70家药品生产企业药用辅料的使用情况以表格填报和现场检查相结合的方式进行调查,并对结果进行总结分析。结果目前我国药品生产企业药用辅料的使用和管理存在水平参差不齐、质量标准不统一、批准文号不统一等问题。结论根据我国辅料使用和管理实际情况,应从法规建设、标准建立、日常监管和药品GMP认证等方面,完善对药用辅料的管理。
Objective To investigate the current situation and existing problems in the use and management of pharmaceutical excipients in China,put forward opinions and suggestions and provide a reference for production supervision and certification inspection.Methods The use of pharmaceutical excipients was analyzed based on the investigation on 70 manufacturers with different scales and production of different types of preparation in seven provinces and districts in China in the form of table filling and on-site inspection. Results Currently, uneven levels, non-conformant quality standard and inconsistent approval numbers existed with regard to the use and management of pharmaceutical excipients manufacturers in China.Conclusion In accordance with the actual situation of use and management of pharmaceutical excipients in China,and the proposals were made to improve management in terms of laws and regulations construction,standard establishment,routine supervision,GMP certification,etc.
出处
《中国药事》
CAS
2014年第9期934-938,共5页
Chinese Pharmaceutical Affairs
关键词
药用辅料
使用管理
质量标准
批准文号
日常监管
pharmaceuticalexcipients
useandmanagement
qualitystandards
approvalnumber
daily supervision
