制剂产品工艺验证 模版

制剂产品工艺验证模版 双语版的 很多的药学词汇都在里面

甲苯咪唑片工艺验证草案

Process Validation Protocol

甲苯咪唑片100mg制造工艺验证

Process validation of Mebendazole 100mg Tablets

制剂产品工艺验证模版 双语版的 很多的药学词汇都在里面

目录CONTENT TABLE

目录CONTENT TABLE ........................................................................................................................ 2 1.

1.1 1.2 1.3 1.4

背景介绍INTRODUCTION .......................................................................................... 4

验证产品基本信息BASIC INFORMATION OF VALIATIONED PRODUCT ................. 4 背景Background ........................................................................................................................ 4 目的Purpose ............................................................................................................................... 4 范围Scope ................................................................................................................................... 5

2. 3.

3.1 3.2 3.3 3.4

责任RESPONSIBILITY ................................................................................................ 7 方法APPROACH ........................................................................................................... 8

工艺验证与验证批释放Process validation and release of the validation batch .................. 8 Comparison to biobatch ............................................................................................................. 8 稳定性研究Stability study to this process validation ............................................................. 8 与工艺验证相关的清洁验证Cleaning validation related to this process validation ........... 8

3.5 分析方法与IPC/释放标准Analytical method overview including IPC /release specifications ...................................................................................................................................................... 9 3.6

结果记录与评估的方法Methods for recording & evalusting results ................................... 9

4.

4.1

工艺介绍PROCESS ..................................................................................................... 10

产品处方Product Formulation ............................................................................................... 10

4.1.1 处方Formulation............................................................................................................. 10

4.1.2 原材料合格供户清单Qualified suppliers List of raw materials ................................. 11

4.2 4.3 4.4 4.5

接触容器Immediate containers .............................................................................................. 12 生产设备和设施Manufacturing Equipment and Facility .................................................... 12 工艺流程图Process Flow Diagram ......................................................................................... 13 关键工艺参数与变量Critical Process Parameters and Variables ...................................... 14

5

5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9

工艺验证过程PROCESS VALIDATION .......................................................................... 15

粘合液制备Prepare binding solution ..................................................................................... 15 干混工序Dry-mixing (Pre-mixing) ......................................................................................... 17 湿法制粒和干燥工序Wet Granulation and Drying ............................................................. 19 整粒工序Breaking .................................................................................................................... 22 不加硬脂酸镁的混合Mixing without Magnesium stearate ................................................. 23 加硬脂酸镁的混合Mixing with Magnesium stearate ........................................................... 25 中间体桶料In drums ............................................................................................................... 29 压片工序The tableting process ............................................................................................... 31 贮存时间Holding time study ................................................................................................... 35

6 验证中偏差/变更处理DEVIATION AND CHANGE HANDLING...................................... 37

制剂产品工艺验证模版 双语版的 很多的药学词汇都在里面

7 8

培训TRAINING ............................................................................................................... 37 参考文献REFERENCE ..................................................................... 错误！未定义书签。

制剂产品工艺验证模版 双语版的 很多的药学词汇都在里面

1. 背景介绍INTRODUCTION

1.1 验证产品基本信息BASIC INFORMATION OF VALIATIONED PRODUCT

1.2 背景Background

生产的甲苯咪唑100mg口服片剂的主要成分是甲苯咪唑，自1988年投放到生产后，先后进行了三次工艺验证，详细情况参见下表。

自2001年验证完成后，A的生产工艺和生产设备均没有发生变更，未出现与工艺相关的不符合事件。依据中国cGMP第七章/第58条、工艺验证管理程序SMP-VMP006有关周期性再验证的规定，在2001年成功实施工艺验证后在2006年需要对A100mg口服片剂的制造工艺再次进行全面的验证，确保现行的工艺 …… 此处隐藏：5822字，全部文档内容请下载后查看。喜欢就下载吧 ……