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1、APIC原料药厂清洁验证指南（201405中英文）ACTIVEPHARMACEUTICALINGREDIENTSCOMMITTEE(APIC)GUIDANCEONASPECTSOFCLEANINGVALIDATIONINACTIVEPHARMACEUTICALINGREDIENTPLANTSAPIC原料药工厂中清洁验证指南May2014TableofContents1.0FOREWORD前言2.0OBJECTIVE目的3.0SCOPE范围4.0ACCEPTANCECRITERIA可接受标准4.1Introduction介绍4.2MethodsofCalculatingAccept
2、anceCriteria可接受标准的计算方法4.2.1.Acceptancecriteriausinghealth-baseddata使用基于健康数据的可接受标准4.2.2AcceptancecriteriabasedonTherapeuticDailyDose基于日治疗剂量的可接受标准4.2.3.AcceptancecriteriabasedonLD50基于半数致死量的可接受标准4.2.4GeneralLimitasacceptancecriteria作为可接受标准的通用限度4.2.5SwabLimits擦拭限度4.2.6RinseLimits淋洗限度4.2.7Rational
3、efortheuseofdifferentlimitsinpharmaceuticalandchemicalproduction在药品和化学生产中使用不同限度的合理性5.0LEVELSOFCLEANING清洁级别5.1Introduction介绍5.2CleaningLevels清洁级别5.3CleaningVerification/Validation清洁验收/验证6.0CONTROLOFCLEANINGPROCESS清洁过程的控制7.0BRACKETINGANDWORSTCASERATING分类法和最差情况分级法7.1Introduction介绍63/637.2Bracket
4、ingProcedure分类法程序7.3CleaningProcedures清洁程序7.4WorstCaseRating最差情况分级8.0DETERMINATIONOFTHEAMOUNTOFRESIDUE残留量检测8.1Introduction介绍8.2ValidationRequirements验证要求8.3SamplingMethods取样方法8.4AnalyticalMethods分析方法9.0CLEANINGVALIDATIONPROTOCOL清洁验证方案9.1Background背景9.2Purpose目的9.3Scope范围9.4Responsibility职责9.5
5、SamplingProcedure取样程序9.6Testingprocedure分析方法9.7Acceptancecriteria可接受标准9.8Deviations偏差9.9Revalidation再验证10.0VALIDATIONQUESTIONS验证问题11.0REFERENCES参考文献12.0GLOSSARY词汇13.0COPYRIGHTANDDISCLAIMER版本及声明63/631.0FOREWORD前言TheoriginalversionofthisguidancedocumenthasnowbeenupdatedbytheAPICCleaningValidati
6、onTaskForceonbehalfoftheActivePharmaceuticalIngredientCommittee(APIC)ofCEFIC.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。TheTaskForcemembersare:-以下是工作组的成员AnnickBonneure,APIC,BelgiumTomBuggy,DSMSinochemPharmaceuticals,TheNetherlandsPaulClingan,MacFarlanSmith,UKAnkeGrootaert,JanssenPharmaceutic
7、a,BelgiumPeterMungenast,MerckKGaA,Germany.LuisaPaulo,HovioneFarmaCienciaSA,PortugalFilipQuintiens,Genzyme,BelgiumClaudeVandenbossche,AjinomotoOmnichem,BelgiumJosvanderVen,AspenOssB.V.,TheNetherlandsStefanWienken,BASF,Germany.Withsupportandrev
