药品GMP培训(现场检查程序)演示文稿.pptVIP

整 改 措 施 依据本国法规 改正不良状况 关闭工厂 吊销执照 产品召回 进驻和简报/开幕会 定点巡视 查清事实并评价 针对检查计划观察检查进展 调整检查活动 最终评价/建议 与管理层讨论并结束检查/闭幕会 按照时间安排写报告 时 间 表 启 程 位置 联系 时间 介绍 转转 陪同人员 是一套系统的方法 包括人际交往的技巧 找出缺陷 注意是什么出了问题 需要每名检查员的参与 记住，检查…… 查清事实的方法 向前追索 向后追索 随机检查 提 问…… 要以这样的方式提问: 什么 为什么 何时 怎样 哪里 谁 沉默具有很大的威力 检 查 听得好 - I 别说话! 令讲解人畅所欲言 要平易近人 向讲解人表明你感兴趣的东西 消除干扰 要能够理解讲解人的观点 检 查 听得好 - II 耐心点 控制情绪 别责备 询问 停下,观察并听听 These are the objectives that we have for this programme: 1.We aim to provide you with training to ensure that you have an understanding of all aspects of the WHO guidelines on the inspection of pharmaceutical and vaccine manufacturers. The programme is designed and developed in such a way that your input is important throughout the training. 2.Therefor the programme has been designed to enable you to bring in your real life inspection experiences, so that we can share knowledge and explore ways to respond to these challenges. We will review, both in terms of education and previous experience, the qualities of an inspector of pharmaceutical manufacture appointed by the national regulatory authority. We will look at the different types of roles that an inspector can adopt during an inspection. We will talk about communications (since an inspector should be a good communicator) and the types of behaviour which is preferable for an inspector to assume during an inspection. To review the activities that need to be carried out when you are preparing for an inspection. We will look at the key issues relating to the preparation for an inspection and review the particular issues that relate to inspections in your country. We will review the different types of inspection that are carried out by regulatory authorities. We will look at the situations when each of these types of inspection is most appropriate. We will discuss the drug regulatory authority inspections in your country and review any specific issues relating to them The inspectorate represents the enforcement arm of the na