API清洁验证译文详细整理.docx

ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC) GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS 原料药工厂中清洁验证指南 May 2014 1.0FOREWORD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 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,?BelgiumTom?Buggy,?DSM?Sinochem?Pharmaceuticals,?The?NetherlandsPaul?Clingan,?MacFarlan?Smith,?UKAnke?Grootaert,?Janssen?Pharmaceutica,?BelgiumPeter?Mungenast,?Merck?KGaA,?Germany.Luisa?Paulo,?Hovione?Fa