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………………………………….………………..………………………52沈阳抗生素厂编号:ZL398质量手册QAManual页号:2/112版本号:00颁发部门:质量部执行日期:年月日Q.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第3页共78页编号:时间:2021年x月x日书山有路勤为径,学海无涯苦作舟页码:第3页共78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……………………………...