精选优质文档-倾情为你奉上原料药工厂中清洁验证指南May 2014Table of Contents1.0 FOREWORD前言2.0 OBJECTIVE目的3.0 SCOPE范围4.0 ACCEPTANCE CRITERIA可接受标准4.1 Introduction介绍4.2 Methods of Calculating Acceptance Criteria可接受标准的计算方法4.2.1. Acceptance criteria using health-based data使用基于健康数据的可接受标准4.2.2 Acceptance criteria based on Therapeutic Daily Dose基于日治疗剂量的可接受标准4.2.3. Acceptance criteria based on LD50基于半数致死量的可接受标准4.2.4 General Limit as acceptance criteria作为可接受标准的通用限度4.2.5 Swab
