文档介绍：新建兽用粉剂、散剂、预混剂GMP验收细则
of accountability, redress of orders and prohibitions. Strengthening the honesty and self-
新建兽用粉剂、散剂、预混剂GMP验收细则
of accountability, redress of orders and prohibitions. Strengthening the honesty and self-discipline of leading cadres honesty in politics and education work, enhance leaders ability to resist
of accountability, redress of orders and prohibitions. Strengthening the honesty and self-discipline of leading cadres honesty in politics and education work, enhance leaders ability to resist
of accountability, redress of orders and prohibitions. Strengthening the honesty and self-discipline of leading cadres honesty in politics and education work, enhance leaders ability to resist
附件
新建兽用粉剂、散剂、预混剂GMP检查验收细则
一、粉剂、散剂、预混剂（包括粉剂/预混剂、散剂,下同)生产线从投料到分装应具备全过程自动化控制、密闭式生产工艺，以及相应的设备设施。
二、粉剂、散剂、预混剂产品工艺流程需对原辅料做预处理（如干燥、粉碎、逐级混合等）或具有特殊生产工艺（如中药提取等）的，其设备设施应与自动化控制、密闭式生产系统进行无缝连接。
三、中药散剂车间工艺设计应从中药材拣选、清洗、干燥、粉碎等前处理工序开始，并根据中药材炮制、提取的需要，设置相应的功能区，配备相应设备。
四、粉剂、散剂、预混剂应分别设置独立的生产车间，并由具有医药工业设计资质的单位设计。生产车间应配备适宜的温湿度控制系统，并参照洁净室（区）要求管理。
五、粉剂、散剂、预混剂车间应设置独立的中央除尘系统，在粉尘产生点配备单独的有效除尘装置，称量、投料等操作应在单独除尘控制间中进行。中药粉碎应设置独立除尘及捕尘设施。生产区域粉尘浓度应达到环保和安全生产要求。
of accountability, redress of orders and prohibitions. Strengthening the honesty and self-discipline of leading cadres honesty in politics and education work, enhance leaders ability to resist
of accountability,