APIC原料药厂清洁验证指南(201405中英文).docxVIP

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 VALIDATIONIN ACTIVE PHARMACEUTICAL INGREDIENT PLANTSAPIC原料药工厂中清洁验证指南May 2014Table 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 Pharmaceuticals, The Netherlands Paul Clingan, MacFarlan Smith, UK Anke Grootaert, Janssen Pharmaceutica, Belgium Peter Mungenast, M