江西隆莱生物制药有限公司APR-LXXX-X-20XX-01产品质量年度回顾（产品名称）（****年）起草：审核：批准：****年 **月 ** 日--**** 年 ** 月 ** 日APR-LXXX-X-20XX-01目录一、一般情况汇报...............................................................................................31.1 生产情况汇总.........................................................................................31.2 主要生产设备.........................................................................................31.3 工艺流程图.............................................................................................41.4 关键原材料信息.....................................................................................4二、质量分析.......................................................................................................42.1 产品质量规格/分析方法及变更 ...........................................................42.2 质量数据分析.........................................................................................52.3 稳定性考察.............................................................................................8三、生产过程分析...............................................................................................83.1 关键工艺参数统计及分析 ....................................................................83.2 中间体质量数据分析.............................................................................93.3 各批产品收率统计及分析 ....................................................................9四、生产偏差/OOS/不合格 ..............................................................................104.1 生产偏差...............................................................................................104.2 OOS.......................................................................................................104.3 不合格...................................................................................................10五、变更...........
