1 / 44 XX 宏 业 药 业 XX 验 证 方 案 （ 初 案 ） 名 称 ： 天 麻 素 注 射 液 （ 2ml： 0.2g） 工 艺 验 证 方 案 部 门 职 务 签 字 日 期 验 证 方 案 起 草 人 验 证 方 案 审 核 人 验 证 方 案 批 准 人 小 容 量 注 射 剂 车 间 天 麻 素 工 艺 验 证 --第 1页小 容 量 注 射 剂 车 间 天 麻 素 工 艺 验 证 --第 1页2 / 44 目录 1. 验证小组成员及职责···································3 2. 产品概述·············································4 3. 验证目的·············································4 4. 验证X 围·············································4 5. 小容量注射剂车间天麻素注射液验证的培训 ··············4 6. 验证时间和安排·······································5 7.工艺描述··············································5 8. 验证前确认及准备·····································7 9. 验证内容·············································12 10. 生产线环境检测······································35 11. 成品检验············································43 12. 持续稳定性考察······································44 13. 再验证周期··········································44 14. 结果分析与评价······································44 15. 验证结果············································45 16. 验证合格证书·······························...
VIP
