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[资源] 【转帖】甲苯咪唑片工艺验证草案（中英对照）

目录CONTENT TABLE

目录CONTENT TABLE    3
1.    背景介绍INTRODUCTION    5
1.1    验证产品基本信息BASIC INFORMATION OF VALIATIONED PRODUCT    5
1.2    背景Background    5
1.3    目的Purpose    6
1.4    范围Scope    6
2.    责任RESPONSIBILITY    9
3.    方法APPROACH    10
3.1    工艺验证与验证批释放Process validation and release of the validation batch    10
3.2    Comparison to biobatch    10
3.3    稳定性研究Stability study to this process validation    10
3.4    与工艺验证相关的清洁验证Cleaning validation related to this process validation    11
3.5    分析方法与IPC/释放标准Analytical method overview including IPC /release specifications    11
3.6    结果记录与评估的方法Methods for recording & evalusting results    12
4.    工艺介绍PROCESS    13
4.1    产品处方Product Formulation    13
4.1.1 处方Formulation    13
4.1.2 原材料合格供户清单Qualified suppliers List of raw materials    14
4.2    接触容器Immediate containers    15
4.3    生产设备和设施Manufacturing Equipment and Facility    15
4.4    工艺流程图Process Flow Diagram    16
4.5    关键工艺参数与变量Critical Process Parameters and Variables    17
5    工艺验证过程PROCESS VALIDATION    18
5.1    粘合液制备Prepare binding solution    18
5.2    干混工序Dry-mixing (Pre-mixing)    20
5.3    湿法制粒和干燥工序Wet Granulation and Drying    22
5.4    整粒工序Breaking    25
5.5    不加硬脂酸镁的混合Mixing without Magnesium stearate    26
5.6    加硬脂酸镁的混合Mixing with Magnesium stearate    28
5.7    中间体桶料In drums    32
5.8    压片工序The tableting process    34
5.9    贮存时间Holding time study    38
6    验证中偏差/变更处理DEVIATION AND CHANGE HANDLING    40
7    培训TRAINING    40
8    参考文献REFERENCE    40

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