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    2021年药品生产流程图.pdf

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    2021年药品生产流程图.pdf

    学习资料收集于网络,仅供参考学习资料GMP 车间生产流程图一、药品生产主流程图:二、物料供应流程图:1、定点供应商确认流程图:供应商的质检报告物料供应采购、入库、贮存、发放药品生产过程生产准备、半成品、成品厂房设施空调净化系统水、电、气系统设备验证、选型人员卫生清洁工艺用水取样、监测定点供应商的确认物料定点采购物料入库物 料贮存物料发放供应商的资质考察人员、工服、器材、工作区卫生药品销售出厂质量检验、控制、处理精品w o r d 学习资料 可编辑资料-精心整理-欢迎下载-第 1 页,共 7 页学习资料收集于网络,仅供参考学习资料供应商基本请验单物料情况调查表质检报告试生产单供应商质量认证审核报告合格归档不合格归档2、物料定点采购流程图核实制定签订进行依据订单交库房办理退货单3、物料入库流程图采购订单请验单来料合格证取样证检验指令单供应商检验报告取样记录分样记录合格不合格4、物料贮存流程图填写合格不样品检验小批量试生产定点供应商的确认结论入定点供应商名册合格供应商档案取消定点供应入取消定点供应商名册物料定点采购物料库存量生产计划物料采购来料清点核对物料入库清单物料入库入库前准备请验样品分 样检 验结果供应科退货办理入库入库单定期复审物料供应计划定点供应订单物料进厂编号定期盘存复查请验单(复检)物料复验检验报告合格否物料贮存物料发放原辅料留样供应商收料记录称量记录库存货位卡温湿度记录物料入库总帐物料分类台帐检验记录.检验报告不 合 格 质检 报 告 单不合格证合格质检报告单合格证精品w o r d 学习资料 可编辑资料-精心整理-欢迎下载-第 2 页,共 7 页文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 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HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3学习资料收集于网络,仅供参考学习资料合格5、物料发放流程图下台帐物料报损单不合格品处理报告不合格品销毁记录发料准备限额发料清点核对签字记帐生产车间储运科物料监控记录限期整顿通知单物料停止发放证留样记录留样观察记录包装指令领料单标签、说明书发放记录物料发料记录精品w o r d 学习资料 可编辑资料-精心整理-欢迎下载-第 3 页,共 7 页文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 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ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3文档编码:CY4O7F1S3S9 HV1Y7S6B3F1 ZJ9X1M7P9X3学习资料收集于网络,仅供参考学习资料三、工艺用水系统流程图合格不合格不合格合格四、人员卫生和工艺卫生流程图定期验证验证报告查原因改进工艺或设备再验证制水工艺用水检测报告生产车间人员进出生产区管理工服管理外来人员进入生产区批条外来人员进入生产区登记表进出程序工作区清洁消毒区域、设备清洁消毒记录工器具、清洁工具清洁消毒生产人员工艺用水制备系统验方案验证记录车间检测记录质检定期检测记工服 收发记录工服清洗灭菌记录工服编码记录精品w o r d 学习资料 可编辑资料-精心整理-欢迎下载-第 4 页,共 7 页文档编码:CY4O7F1S3S9 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