小容量注射剂车间天麻素工艺验证.pdf

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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

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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········································46

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1.验证小组的成员及职责

XX部门资质职责

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2.产品概述

天麻素注射液为中枢神经系统用药，本品为无色的澄明的液体；用于神经衰弱、

神经衰弱综合症及血管神经性头痛症等，亦可用于脑外伤性综合症、眩晕症如美

尼尔病、药性晕眩、外伤性晕眩、空发行耳聋、前疾神经元炎、推基底动脉供血

不足等。该产品本次验证按天麻素注射液工艺规程，组织连续生产3批产品，规

格为2ml：0.2mg；批量为40万ml，使用的主要设备通过验证，按验证方案进

行取样，按国家的质量标准进行检验，并收集分析数据，验证完毕后，根据验证

进程及检验结果，对配制（包括除菌过滤）、灌封、检漏等主要生产工序的相关

参数进行确认，进一步完善生产工艺规程。

3.验证的目的

按照现有的生产设备和生产条件及批准的生产工艺连续三个批次的工艺验证，通

过验证证明现有的生产设备和生产环境能够生产初出始终如一的质量稳定的产

品。

4.验证X围

本次验证适用于小容量注射剂车间天麻