原料药生产质量管理手册

沈阳抗生素厂编号：ZL398质量手册QAManual页号：1/112版本号：00颁发部门：质量部执行日期：年月日文件内容：INDEX：1、质量方针………………………………………………………………………….………...4QualityPolicy………………………………………………………………………….……...42、质量管理原则…...……………………………………………………………….……………4PrinciplesforQualityAssurance…………………………………………...…….…………..43、定义………………….………………………………………………………...……………….6Definitions…………….……………………………………………………….……………….64、人员管理………....……………………………………………………..…………………….10PersonnelandOrganization…………………………………………………....…………...105、培训……………………………………...…….……………….…….……………….………15Training………………………………...…….……………….…….……….….….…………156、厂房……………………………………………………………………………………...……16Premises…………………………………………………………………………..………......167、消毒与卫生……………………………………………………………………..………..…21SanitationandHygiene……………………….………………..……………………….……..218、物料供应………………………………….………………..………………………………27MaterialsSupply…………………………….………………..………………………………279、生产文件与记录………………………………….………………..………………………30Manufacturing-DocumentationandRecords…….………………..………………………3010、原料药生产………………………………….………………..…………………………….39ManufactureOfAPI…………………………….………………..…………………………….3911、质量文件与记录………………………………….………………..………………………52Q.A.DocumentationandRecords…………………….………………..……………..………5212、质控处文件与记录………………………………….………………..…………….………63QualityControl…………………………….………………..…………………………..…...…6313、检验报告单………………………………….………………..…………………….………84CertificateofAnalysis…………………………….………………..……………………..……8414、有效期和复检期………………………………….………………..………………..………84沈阳抗生素厂编号：ZL398页号：2/112质量手册QAManual版本号：00执行日期：见首页ExpiryandRetestDating……………………………….……………..………………….……8415、留样……………………………….…………………….…………..…………………….…85Reserve/RetentionSamples………….…………………….…………..………………….…8516、仓储………………………………….………………..………………………………….…86WarehousingandDistribution……….…………………….…………..……………………8617、委托生产/委托检验………………….………………..……………………………………96ContractManufactureandAnalysis…….………………..……………………………...…9618、验证……………………………….………………..…………………………………..…99Validations……………………………….………………..…………………………………9919、客户投诉与召回…………………….………………..…………………………………..106CustomerComplaintsandRecalls…….………………..…………………………………10620、自检……………………………….………………..……………………………………108SelfInspection………………………….………………..………………………………….10821、产品质量回顾…………………….………………..…………………………………….109ProductQualityReview……………….………………..……………………………………10922、变更控制…………………….………………..……………………………………………110ChangeControl………………….………………..…………………………………………110发放范围：全厂文件复审：复审人复审日期复审意见沈阳抗生素厂编号：ZL398页号：3/112质量手册QAManual版本号：00执行日期：见首页编审批过程：起草人审核人批准人部门质保处质保处质量部总工程师签名日期沈阳抗生素厂编号：ZL398页号：4/112质量手册QAManual版本号：00执行日期：见首页1、质量方针QualityPolicy：“质量”的定义是指为符合预定用途所具有的一系列固有特性的程度。质量体系是基于一定的设备、人员基础上通过设计、文件化、执行及控制来实现预期质量、纯度、安全性及稳定性等目标的系统。根据质量系统分工，各部门包括研发、生产、技术、仓储、销售、质量和质检等部门分工合作，共同实现质量方针。质量管理体系主要包括验证、GMP、文件、内审、培训及客户投诉。质量目标的最终实现是基于全员范围质量方针、质量通则贯彻落实基础上实现的。Our‘QUALITY’philosophyisasynthesisorworldguidelines,lawsregulationsandbesthumanrequirements,whichenableustocatertothebestneedsofourcustomers.The‘QUALITY’systemisdesigned,documented,implementedandcontrolledwhichisbasedoninstrumentation,manpowerandmanagementdesiresoastogiveaassurancethattheproductsmanufacturedbythecompanywillbeconsistentintheirintendedusewithrespectivetoquality,purity,safety,efficacyandstability.Itismonitoredbyateamresponsibleforvalidation,GMP,documentation,self-audits,trainingandmarketcomplaints.Theultimate‘QUALITY’goalisachievedbyeveryoneadheringtoqualitypolicyandprinciple.2、质量管理原则PRINCIPLESFORQUALITYASSURANCE2.1我公司保证产品质量安全可靠，我厂质量管理能够实现质量目标。Wepledgedtoassurethatitsproductsandservicesareofhighqualitywithregardtosafety,propertiesofuseandreliability.ThemanagementofShenyangAntibioticManufactureisfullycommittedtosupportingallnecessarymeasures.2.2质量目标基于下列要求的制定：QualityAssurancecomprisesthetotalityofallmeasuresdesiredtoachievethisaimtakingintoaccount（1）客户的需求Theneedsofourcustomers（2）相关法规要求Therelevantlegalrequirements沈阳抗生素厂编号：ZL398页号：5/112质量手册QAManual版本号：00执行日期：见首页（3）工艺要求Thestateoftheart（4）内控质量标准。Theinhousestandards2.3产品质量的保证是研发、供应、生产、仓储、销售等部门必须各自制定并完成相应质量目标从而实现的。Thequalityassuranceofproductsandservicesisthereforeacompanyobligation,whichmustbesharedbythedepartmentsfordevelopment,purchasing,manufacturing,distribution,marketingandbyallothermembers.2.4质量部的职责：TheQualityAssuranceDepartment’sDuty：（1）质量标准的建立及更新；Ensuresthatappropriatequalitystandardsareset,maintainedandkeptuptodate.（2）生产过程质量监督管理；Supervisestheimplementationofallnecessarymeasuresthroughtheline/manufacturingfunctions.（3）提高全员质量意识。Playsaleadingroleinpromotingqualityawarenessthroughoutthecompany.2.5质量部的工作：ThetasksoftheQualityAssuranceDepartmentinclude:（1）生产及委托生产生产过程监督指导；Technicalguidanceandsupervisiontodifferentmanufacturingunitsownedbythecompanyandthirdparties.（2）协调相关部门建立各项标准；Settingstandardsinco-operationwithalldepartmentsconcerned.（3）生产储存及发运的全过程实施质量管理；Implementingqualityassurancemeasuresatalllevelsofmanufacture,storageanddistribution.（4）组织应对突发事件及产品召回；Organizingemergencyandrecallprocedures.沈阳抗生素厂编号：ZL398页号：6/112质量手册QAManual版本号：00执行日期：见首页2.6质量部长直接向厂长汇报工作，独立于销售、生产、供应及研发部门。QualityAssuranceDepartmentministerreportstoDirectorofthecompanysoastoensureindependencefrommarketing,manufacturing,purchasingandR&Ddepartments.2.7遵守有关部门各项法律法规要求。Promisetoobservealltherelevantauthoritiesonqualityassu