【作者】 宋丽丽； 韩紫岩； 高洁；

【Author】 Song Li-li Han Zi-Yan Gao Jie (school of Pharmacy,Henan University,Kaifeng 475004)

【机构】 河南大学药学院；

【摘要】 目的:了解药品生产企业对我国新版药品GMP的认知和实施准备情况.方法:采用非概率抽样法,按17%的比例对河南省药品生产企业抽样,进行问卷调查.结果与结论:样本企业对新版药品GMP的变化要点有较高的认知度,88.9%的对新版药品GMP的要求可以承受,但需进行较大投入;样本企业在关键岗位人员、物料与产品管理、记录类文件管理、质量控制与质量保证等变化较大的关键环节,已不同程度的接近新标准要求,但需进一步强化、规范和改善.新版药品GMP的新要求尤其是质量管理方面的新规定是实施的重点和难点.更多还原

【Abstract】 Objective:To understand the cognition and implementation of the preparations of pharmaceutical manufacturers to the new version of GMP.Method:Non probability sampling methods was used to do questionnaire survey,the proportion of 17S sample of the pharmaceutical manufacturers in Henan Province.Results and Conclusion:The sample enterprises have a higher awareness to the changes in the new version of GMP,88.9%of companies can afford requirements of the new version of GMP,but needing greater investment;the sample of enterprises,in key positions in personnel,materials and product management,record class document management, quality control and quality assurance and other key aspects greater changed,has different degrees approaching to the new standards,but needing further reinforcement and standardization and improvement.New requirements of the new version of GMP,especially the new provisions in quality management is to the important and difficult to execute regularly.更多还原