文档介绍：关于组织全区抗艾滋病、结核病及疟疾类药品生产企业填报调查问卷的函附件药品生产企业实施药品GMP(修订)过程中存在差距的调查问卷QuestionnaireforInvestigationoftheGapsofPharmaceuticalEnterprisesinRelationtotheGMPGuidelines(revisedin)在中国药品GMP(修订)的总体实施层面,您主要欠缺哪些知识,有哪些培训需求?WhatareyourmajorknowledgeshortagesandneedfortrainingintheframeoftheimplementationoftheChineseGMPGuidelines(revisedin)?以风险为基础的质量保证体系Riskbasedqualityassurancesystem质量受权人和其它关键人员Qualifiedpersonandotherkeypersons人员培训PersonnelTraining文件体系Documentationsystem空调净化系统HVACsystem工艺用水制备Processwaterpreparation设备的校准,确认和预防性维护Equipmentcalibration,qualification,andpreventivemaintenance工艺验证Processvalidation清洁验证Cleaningvalidation产品质量回顾Productqualityreview库房Warehouse供应商确认Supplierqualification委托生产,委托检验Contractmanufacturing/testing质控实验室QClaboratory偏差、纠正与预防措施Deviation/CAPA超标检验数据调查OOSinvestigations变更控制Changecontrol您所建立的质量保证体系是否以确保产品安全而且符合注册批准要求为目的,以科学为准则而且以风险管理为基础?plywiththerequirementsoftheMarketingAuthorization?您的质量保证体系把那些可能影响产品质量的关键参数考虑在内了吗?Doesyourqualityassurancesystemconsidercriticalparametersthatmayimpactonproductquality?那些关键参数及其控制范围是经过风险评估确定的吗?它们包含在验证总计划中了吗?ArethosecriticalparametersandtheircontrolrangesdefinedbyriskassessmentandincludedintheVMP(ValidationMasterPlan)?您有用于确定那些参数及其范围的系统性方法吗,譬如“失效模式影响分析”?IsthereasystematicapproachsuchasFMEA(FailureModeEffectAnalysis)hoseparametersandranges?您公司有风险评估的书面程序吗,特别是(相关的)决策程序?panyhaveawrittenriskassessmentprocedure,especiallyforthedecisionmakingprocedure?对于质量受权人和其它关键人员(生产、质控、质保、仓储、工程等),您是否系统地制定了清晰明确的岗位说明?Haveyouestablishedawell-definedjobdescriptionsystemforQualifiedPersons(QP)andotherkeypersons(production,qualitycontrol,qualityassurance,warehousing,engineering,etc.)?质量保证或质量受权人员在质量事务和成品批放行方面,有独立决策权吗?Isthereanindependenceofqualityassurance/QualifiedPersoninmakingdecisionofqualitymattersandbatchreleaseoffinishedproducts?在法规事务、检验技术和生产技术方面,对质量受权人和其它关键人员有持续性的培训吗?DotheQualifiedPersonandotherkeypersonsreceivecontinuoustraininginregulatoryaffairsandinanalyticalandproductiontechnology?相关人员在岗位说明书上签字了吗?Arethejobdescriptionssignedbythepeopleconcerned?现场是否有