The original 55-page document is still divided into 13 chapters:原来的55页文件现在仍分为13章:Foreword 前言Objective 目的Scope 范围Acceptance criteria 可接受标准Levels of Cleaning 清洁分级Control of Cleaning Process 清洁工艺控制Bracketing...
The protocol should also explain how any deviation from the acceptance criteria will be managed....
The proposed acceptance criteria should be justified for thefollowing:对于下面拟定的接受标准应说明是合理的:Products submitted in NDAs and ANDAs where the applicant’s proposed acceptance criteria are greater than ICH Q3A...
As (further) examples for acceptance criteria and their calculation the document lists:文件中给出了可接受标准及其计算样例:Acceptance criteria using health-based data (ADE, MACO)采用健康的数据(ADE、MACO)计算可接受标准Acceptance criteria...
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