药品生产中对偏差调查.ppt

药品生产中对偏差的调查Investigation of Deviation 原 料 药 制 造 的 GMP GMP for API Manufacture 偏差的调查 Investigation of Deviation 何谓偏差 What’s Deviation 定义 Definition 实例 Examples 分类 Classification 偏差的调查 Investigation of Deviation 谁来处理偏差 Who’s going to deal with deviations 质量部门的职责 Quality unit(s) responsibility 生产作业的职责 Production Activities responsibility 偏差的调查 Investigation of Deviation 如何对待偏差 How should we do for deviations 报告 Report 调查 Investigate 后续检查 Follow up 归档 Archive 何谓偏差 What’s Deviation 对批准的指令或规定的标准的偏离。 Departure from an approved instruction or established standard. (ICH API GMP Guide) 偏差实例 Deviation Examples 生产操作 Production 包装和贴签 Packaging Labeling 物料管理 Material Management 设施和设备 Facilities Equipment 实验室控制 Laboratory Controls 质量部门 Quality Unit 验证 Validation 员工培训 Employee Training 生产操作 Production 关键工艺参数的实际值超出规定范围 Actual results for critical process parameters exceed their specified range 实际产率偏离预期范围 Actual yields departure from their expected ranges 包装和贴签 Packaging Labeling 所用包装材料无法追溯 The packaging materials used are not traceable 发出,使用和退回标签无法平衡 The quantities of labels issued, used, and returned are not reconciled 物料管理 Material Management 物料供应商未经质量部门核准 The material is not from the supplier approved by the quality unit 物料容器上没有标上指定的编号、批号或接受号 The containers of material are not identified with the assigned distinctive code, batch, or receipt number 设施和设备 Facility Equipment 设施或设备的破损可能会影响产品质量The damage on facility or equipment with potential impact on product quality 关键仪器设备的校验结果不符合规定的标准 Calibration results on critical instruments or equipment do not meet the approved standards 实验室控制 Laboratory Controls 实际测试结果不符合质量规格 Actual testing results are Out Of Specifications 所用的物料或仪器超出其有效期 The materials or instrument used are out of their expiration dates 质量部门