工艺验证草案--产品工艺验证(PDF 38页)

目录CONTENT TABLE ... 2
1. 背景介绍INTRODUCTION  4
1.1 验证产品基本信息BASIC INFORMATION OF VALIATIONED PRODUCT  4
1.2 背景Background .... 4
1.3 目的Purpose .. 4
1.4 范围Scope ...... 5
2. 责任RESPONSIBILITY ...... 7
3. 方法APPROACH 8
3.1 工艺验证与验证批释放Process validation and release of the validation batch . 8
3.2 Comparison to biobatch . 8
3.3 稳定性研究Stability study to this process validation ........ 8
3.4 与工艺验证相关的清洁验证Cleaning validation related to this process validation ... 9
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. 工艺介绍PROCESS .. 11
4.1 产品处方Product Formulation ..... 11
4.1.1 处方Formulation  11
4.1.2 原材料合格供户清单Qualified suppliers List of raw materials ...... 12
4.2 接触容器Immediate containers..... 13
4.3 生产设备和设施Manufacturing Equipment and Facility ....... 13
4.4 工艺流程图Process Flow Diagram ........ 14
4.5 关键工艺参数与变量Critical Process Parameters and Variables ... 15
5 工艺验证过程PROCESS VALIDATION ... 16
5.1 粘合液制备Prepare binding solution .... 16
5.2 干混工序Dry-mixing (Pre-mixing) ........ 18
5.3 湿法制粒和干燥工序Wet Granulation and Drying ........ 20
5.4 整粒工序Breaking ........ 23
5.5 不加硬脂酸镁的混合Mixing without Magnesium stearate ..... 24
5.6 加硬脂酸镁的混合Mixing with Magnesium stearate...... 26
5.7 中间体桶料In drums .... 30
5.8 压片工序The tableting process ..... 32
5.9 贮存时间Holding time study  36
6 验证中偏差/变更处理DEVIATION AND CHANGE HANDLING ... 38
7 培训TRAINING ... 38
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