检查员_s14046e.ppt

World Health Organization GMP检查过程 检查员的作用 检查员的作用 目的 1. 讨论理想的检查员的资质 2. 讨论检查员的各种作用 3. 讨论沟通的基本规则 检查员的作用 资质 培训 实践经验 生产和/或质量控制 高等教育资历 药师，化学家，科学家 制药工业背景 检查员的作用 培训 岗位培训 陪同资深检查员 经常更新知识 课程和讨论会 制药技术 微生物学 质量控制统计学 检查员的作用 职责 详细的事实报告 生产和控制 特定产品 评价是否符合GMP 缺陷,偏差 对提高生产和质量控制的建议 取决于国家政策 所有检查员必须达成一致 促使企业遵循GMP 纠正特定的偏差 检查员的作用 人员素质 遵守道德和行为准则 独立的/不违背公众利益 不得同时兼任检查员和顾问 能够抵御影响决定的干扰因素 慎重 检查员的作用 沟通技巧 语言 肢体语言 公司历史和政策 检查员的作用 小组讨论 针对你的小组面临的情况 : 1. 列出检查员不恰当的行为 2. 识别可能会遇到的文化和社会障碍 3. 列举一些你认为的不恰当行为 1. 检查员 2. 被检查的公司 检查员的作用 可能的情形 1. 正在申请许可证的新公司或者工厂 2. 出过问题的老厂 3. 接受第三次检查的当地公司, 没有重大的偏差,但有些小的缺陷且不知道如何改进以达到标准 4. 有良好历史和经过培训的人员的企业，计划建一个新厂，需要在 设计方面提供帮助 5. 国际一流水平的跨国公司 Module 17 | Slide * of 9 January 2006 Part One, 12.1–12.11 This module deals with the role of an inspector. It is a quarter-day session, split into activities as follows: Presentation 30 minutes Group discussions 45-60 minutes Plenary session 30-45 minutes There are three main objectives of this session: Firstly 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. Secondly, we will look at the different types of roles that an inspector can adopt during an inspection. Thirdly, 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. In 1999, the WHO adopted a guideline for GMP inspectorates called “WHO Quality Systems Requirements for National Good Manufacturing Practices Inspectorates”. Some of the issues discussed in this module are addressed in this guideline. (The trainer should be aware of local regulations.) Inspectors should have previous training and practical experience in the manufacture and/or quality control of pharmaceutical products. Suitable educational backgrounds for inspectors are pharmacy, chemistry or microbiology. Per