检查报告检查记录孙京林.ppt

2009-06 * 国际检查报告举例 WHO现场检查报告要求 Annex 6 Guidance on Good Manufacturing Practices (GMP): inspection report 2009-06 * 检查报告缺陷描述的举例 部分文件制定不规范，可操作性不强。(6501) 标签物料平衡限度范围不合理。(6701) 部分批生产记录内容不全，数据不完整。(6801) 质量管理部门未严格履行试剂、试液、对照品的管理职责。(7503) 2009-06 * 检查报告缺陷描述的举例 质量管理部门未严格履行评价成品质量稳定性的职责。(7514) 自检报告内容不完整。(8401) 部分药品生产操作人员的专业技术培训效果不好。(0603) 2009-06 * 检查报告缺陷描述的举例 葛根素原料（批号未按物料发放程序中规定的先拆封的先发放执行。(3801) 枸橼酸（批号称量记录不能准确反映其数量变化。(3802) 大容量注射剂灌装间与洗瓶缓冲间、小容量注射剂灌封间与废弃物通道无压差指示装置。(1602) 2009-06 * 总结 规范的检查记录是保证检查质量的关键 现场检查时不要记录在除检查记录本以外的地方 客观、公正的检查报告，能够正确的体现检查过程，能够真实的反映检查结果，从而保证了人民的用药安全 综合评定企业存在的问题，不要孤立的套用条款。 请大家在后面的现场检查中和今后的检查工作中，从检查记录和检查报告做起， 不断提高检查的水平和质量。 2009-06 * 谢谢大家！ * 在座的各位老师都是我们的检查员，也都在检查记录和报告方面有自己的心得。今天下午要讲的内容是我在结合自己在企业里工作接受不同国家检查和现在作为检查员工作中的一些心得体会。结合这些心得体会和我们现在的检查工作，对我们的现场检查工作提一些要求。已慢慢改变我们当前存在的检查报告模式化等方面的问题，以促进我们今后的检查工作。 * Detail and facts – You need to concentrate on obtaining relevant facts at a detailed level. Note specifics such as room numbers, equipment numbers, document numbers, batch numbers, names etc.It is important that you verify the responses given to your questions as facts, no matter how much you trust the person giving you the information. If the operator says that he has cleaned the mixing vessel and recorded the information in a record, look at the record and verify this. You should never make assumptions and never be satisfied with assurances. Record specific information, not general impressions, e.g. ampicillin 250 mg capsules, batch number X123 was stored in bulk store number 3 where there is no temperature control, monitoring or recording. (Do not just note ampicillin capsules were stored in a bulk store where the temperature is not monitored). Record the detail as you saw it. You need a record of what you see, not what you are told that you should see. If the area is dirty and there is a lot of dust evident, record it as such, even if they say that is isn’t really dust because they had just cleaned the area. Ensure accur