制药行业知识库全行业 EBU 事业部起草部门： 行业及咨询实施部2024 年 7 月<说明：该文件属于用友股份公司内部控制文件，请注意保密>版本控制修改DateAuthorVersionChange Reference2024-02-26V1.0查阅NamePosition分发Copy No.NameLocation目 录第一章行业分类............................................................................................................5第二章行业术语............................................................................................................6第三章制药行业生产特点..........................................................................................143.1生产特点.....................................................143.2生产控制特点.................................................14第四章生产工艺特点..................................................................................................164.1生物制品.....................................................164.2粉针剂.......................................................184.3大输液.......................................................204.4小容量注射剂.................................................224.5滴眼剂.......................................................234.6口服固体制剂.................................................244.7口服液体制剂.................................................254.8原料药.......................................................254.9中药制剂.....................................................26第五章制药行业关键需求..........................................................................................275.1GMP 管理......................................................295.2物料管理.....................................................345.3生产管理.....................................................355.4质量管理.....................................................365.5文件管理.....................................................365.6培训管理.....................................................375.7销售管理....................................
