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 v alidation of Mebendaz ole 100mg Tablets 目录CONTENT TABLE 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 ............................................................................................................ 9 3.1 工 艺 验 证 与 验 证 批 释 放 Process validation and release of the validation batch .................... 9 3.2 Comparison to biobatch ............................................................................................................. 9 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........... 10 3.5 分 析 方 法 与 IPC/释 放 标 准 Analytical method overview including IPC /release specifications ..............................................................
