工藝驗證草案--產品工藝驗證(PDF 38頁)

目錄CONTENT TABLE ... 2
1. 背景介紹INTRODUCTION 4
1.1 驗證產品基本信息BASIC INFORMATION OF VALIATIONED PRODUCT 4
1.2 背景Background .... 4
1.3 目的Purpose .. 4
1.4 範圍Scope ...... 5
2. 責任RESPONSIBILITY ...... 7
3. 方法APPROACH 8
3.1 工藝驗證與驗證批釋放Process validation and release of the validation batch . 8
3.2 Comparison to biobatch . 8
3.3 穩定性研究Stability study to this process validation ........ 8
3.4 與工藝驗證相關的清潔驗證Cleaning validation related to this process validation ... 9
3.5 分析方法與IPC/釋放標準Analytical method overview including IPC /release specifications ...... 9
3.6 結果記錄與評估的方法Methods for recording & evalusting results 9
4. 工藝介紹PROCESS .. 11
4.1 產品處方Product Formulation ..... 11
4.1.1 處方Formulation 11
4.1.2 原材料合格供戶清單Qualified suppliers List of raw materials ...... 12
4.2 接觸容器Immediate containers..... 13
4.3 生產設備和設施Manufacturing Equipment and Facility ....... 13
4.4 工藝流程圖Process Flow Diagram ........ 14
4.5 關鍵工藝參數與變量Critical Process Parameters and Variables ... 15
5 工藝驗證過程PROCESS VALIDATION ... 16
5.1 粘合液製備Prepare binding solution .... 16
5.2 幹混工序Dry-mixing (Pre-mixing) ........ 18
5.3 濕法製粒和幹燥工序Wet Granulation and Drying ........ 20
5.4 整粒工序Breaking ........ 23
5.5 不加硬脂酸鎂的混合Mixing without Magnesium stearate ..... 24
5.6 加硬脂酸鎂的混合Mixing with Magnesium stearate...... 26
5.7 中間體桶料In drums .... 30
5.8 壓片工序The tableting process ..... 32
5.9 貯存時間Holding time study 36
6 驗證中偏差/變更處理DEVIATION AND CHANGE HANDLING ... 38
7 培訓TRAINING ... 38
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