APIC原料药厂清洁验证指南.doc

APIC原料药厂清洁验证指南（201405 中英文） ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC) GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS APIC May 2014 Table of Contents 1.0 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 Limits 擦拭限度 4.2.6 Rinse Limits 淋洗限度 4.2.7 Rationale for the use of different limits in pharmaceutical and chemical production 在药品和化学生产中使用不同限度的合理性 5.0 LEVELS OF CLEANING 清洁级别 5.1 Introduction 介绍 5.2 Cleaning Levels 清洁级别 5.3 Cleaning Verification/Validation 清洁验收/验证 6.0 CONTROL OF CLEANING PROCESS 清洁过程的控制 7.0 BRACKETING AND WORST CASE RATING 分类法和最差情况分级法 7.1 Introduction 介绍 7.2 Bracketing Procedure 分类法程序 7.3 Cleaning Procedures 清洁程序 7.4 Worst Case Rating 最差情况分级 8.0 DETERMINATION OF THE AMOUNT OF RESIDUE 残留量检测 8.1 Introduction 介绍 8.2 Validation Requirements 验证要求 8.3 Sampling Methods 取样方法 8.4 Analytical Methods 分析方法 9.0 CLEANING VALIDATION PROTOCOL 清洁验证方案 9.1 Background 背景 9.2 Purpose 目的 9.3 Scope 范围 9.4 Responsibility 职责? 9.5 Sampling Procedure 取样程序 9.6 Testing procedure 分析方法 9.7 Acceptance criteria 可接受标准 9.8 Deviations 偏差 9.9 Revalidation 再验证 10.0 VALIDATION QUESTIONS 验证问题 11.0 REFERENCES 参考文献? 12.0 GLOSSARY 词汇 13.0 COPYRIGHT AND DISCLAIMER 版本及声明? 1.0 FOREWORD 前言 The original version of this guidance document has now been updated by the APIC Cleaning Validation Task Force on behalf of the Active Pharmaceutical Ingredient Committee (APIC) of CEFIC. 本指南文件的原版本现已由APIC清洁验证工作组代表CEFIC的APIC委员会进行了更新。 The Task Force members are:- 以下是工作组的成员 Annick Bonneure, APIC, Belgium Tom Buggy, DSM Sinochem