国内药品GMP检查员培训标准体系的探索

Exploration of training standard system for drug GMP inspector

目的:规范药品GMP检查员培训标准体系,确保培训效果。方法 :参考WHO的培训管理制度,结合上海市药品GMP检查员的培训经验,探索培训与考核的方法和标准。结果 :建立了按专业(如原料药、外用制剂、口服固体制剂、中药制剂、注射剂、生物制品等)设定的标准培训体系。结论 :建立按专业设定的标准培训体系,为打造一支职业化、专业化的检查员队伍奠定基础。

Objective： To standardize the GMP training system and ensure the training efectiveness. Methods： The methods and standards for training and assessment in training courses were explored by referring to the training management system of WHO and combining the experience training drug GMP inspector in Shanghai. Results： A standard training system set by majors such as raw materials, external preparation, oral solid preparation, traditional Chinese medicine preparation, injection and biological products and so on was established. Conclusion： The establishment of a standard training system set by majors can lay a foundation for creating a professional inspector team.