河北省药品GMP示范基地建设研究探讨

Discussion on the Construction of Pharmaceutical GMP Demonstration Bases of Hebei Province

目的:建设药品GMP示范基地,提高药品生产企业实施GMP整体水平,促进检查员能力提升。方法:以药品生产企业为载体,以检查员实训体系、科研项目合作模式为重点建设内容,与省内先进企业合作建设河北省药品GMP示范基地。结果与结论:建立7家规范的药品GMP示范基地,在检查员多途径培训和GMP科研项目方面进行了积极探索。陆续安排检查员140余人次分批到基地进行实训,检查员的检查能力得到提升,其中12人从一般检查员专家库提升到骨干检查员专家库,5人从骨干检查员专家库提升到组长检查员专家库。与GMP基地合作开展了"诊断式检查""药品生产企业质量体系构建"等研究课题,中心认证技术取得了突破性进展。

Objective： To construct pharmaceutical GMP demonstration bases, to improve the overall level of GMP implementation of the pharmaceutical manufacturers and to promote the improvement of the ability of inspectors. Methods： The pharmaceutical GMP demonstration bases of Hebei Province were established by cooperating with advanced manufacturers in the province, taking the pharmaceutical manufacturers as carriers, the inspector training system and the cooperation mode of scientific research projects as key content of construction. Results and Conclusion： Seven standard pharmaceutical GMP demonstration bases were established. Many training methods of the inspectors and scientific research projects of the GMP were also explored. More than 140 inspectors were trained at the bases in batches. The ability of the inspectors was improved, 12 of the inspectors were promoted from the general inspector pool to the backbone inspector pool, and 5 of the inspectors were promoted from the backbone inspector pool to the leader inspector pool. Hebei Center for Food and Drug Evaluation Certification cooperated with the GMP bases to carry out the research projects, such as diagnostic examination, construction of quality system of pharmaceutical manufacturers, etc. There was a breakthrough in the certification technology research of our center.