关于瓶装水操作的GMP检查清单DOC

GMPCHECKLISTFORBOTTLEDWATEROPERATIONS关于瓶装水操作的GMP检查清单SCOPE范围ThisspecificationincludestheGMPchecklistspecificallydeignedforbottlewateroperations.这个说明书包括了关于瓶装水操作GMP详细的检查清单TABLEOFCONTENTS内容目录Scope范围TableofContents内容目录“GMPChecklistforBottledWaterOperations”关于瓶装水操作的GMP检查清单ThefollowingchecklisthasbeenprovidedtoassistinevaluatingplantoperationsforGMPCompliance.Thechecklistisdesignedsothateachquestioncanbeanswered“yes”or“no”.Thegoalistohaveallquestionsanswered“yes”.Any“no”answerspointoutareaswhichneedimprovement.下表用于厂家在生产时，其GMP是否与要求一致。为方便计，该表把对问题的答案都设计成“是”与“否”。目标应该全部都是“是”。若有“否”，须指出需要改善的具体地方。CHECKLIST检查表PERSONNEL(110.10)人员YES是NO否1.Areallproductionpersonnelcertifiedastohealth?是否所有人员都有健康证书？2.Isproperactiontakenwhenundesirablehealthconditionsoccur?任何不利健康的因素出现时，是否采取适当更正行动？3.Doesmanagementpromotehandwashingbyproductionpersonnel?Sinkneededinproductionarea.管理层是否重视要求员工洗手？在生产区域需有洗手池。4.Iscleanandproperattirewornbyplantpersonnel?员工穿着工作服是否整洁？5.Areunsecureditemsremovedfromworkersinprocessingareas?员工作业区域不安全因素是否被去除？6.Istheuseoftobaccoandfoodandstorageofpersonalbelongingsprohibitedinprocessingareas?作业区是否标示“禁止吸烟，摆放和进食属于员工自己的香烟和食品”？7.Iseffectivehairrestraintworn?是否戴工作帽以防止头发掉落？8.Doproductionpersonneltakeallnecessaryprecautionstopreventproductcontamination?生产人员是否都执行了必要的注意事项来防止生产污染发生？9.Arepersonneltrainedinsanitizingtechniquesandfoodprotectionprinciples?生产人员是否都获得消毒和食品安全准则培训？10.ArecompetentsupervisorypersonnelassignedresponsibilityforassuringcompliancewithGMP’sbyallpersonnel?管理骨干是否责任明确以保证所有员工在GMP方面与要求一致GENERALMANUFACTURINGCHECKLIST一般制造检查表1.0SCOPE范围ThisspecificationincludesageneralGoodManufacturingChecklisttobeusedasatoolbyplantoperationstoevaluateGMPCompliance.该标准包括一个全面产品制造检查表，生产厂管理层用它来评估GMP的符合性。1.0Scope是否所有人员都有健康证书？2.0GeneralGoodManufacturingPracticesChecklist一般制造守则检查表GENERALMANUFACTURINGCHECKLIST一般制造检查表2.0GeneralGoodManufacturingPracticesChecklist一般制造守则检查表3.1ThefollowingchecklisthasbeenprovidedtoassistinevaluatingplantoperationsforGMPCompliance.Thechecklistisdesignedsothateachquestioncanbeanswered“yes”or“no”.Thegoalistohaveallquestionsanswered“yes”.Any“no”answerspointoutareaswhichneedimprovement.AllnumberingwithinthissectioncoincideswithactualnumberingintheGMPProvision.下表用于厂家在生产时，其GMP是否与要求一致。为方便计，该表把对问题的答案都设计成“是”与“否”。目标应该全部都是“是”。若有“否”，须指出需要改善的具体地方。本节中的所有编号与GMP规定的实际编号一致。1.0PERSONNEL人员YES是NO否1.Areallproductionpersonnelcertifiedastohealth?是否所有人员都有健康证书？2.Isproperactiontakenwhenundesirablehealthconditionsoccur?任何不利健康的因素出现时，是否采取适当更正行动？3.Doesmanagementpromotehandwashingbyproductionpersonnel?Sinkneededinproductionarea.管理层是否重视生产员工的洗手要求？在生产区域需有洗手池。4.Iscleanandproperattirewornbyplantpersonnel?员工穿着工作服是否整洁？5.Areunsecureditemsremovedfromworkersinprocessingareas?员工作业区域不安全因素是否被去除？6.Istheuseoftobaccoandfoodandstorageofpersonalbelongingsprohibitedinprocessingareas?作业区是否标示“禁止吸烟，摆放和进食属于员工自己的香烟和食品”？7.Iseffectivehairrestraintworn?是否戴工作帽以防止头发掉落？8.Doproductionpersonneltakeallnecessaryprecautionstopreventproductcontamination?生产人员是否采取了必要的预防措施来防止生产污染发生？9.Arepersonneltrainedinsanitizingtechniquesandfoodprotectionprinciples?生产人员是否都获得消毒和食品安全准则培训？10.ArecompetentsupervisorypersonnelassignedresponsibilityforassuringcompliancewithGMP’sbyallpersonnel?管理骨干是否责任明确以保证所有员工在GMP方面与要求一致GENERALMANUFACTURINGCHECKLIST一般制造检查表2.0PLANTANDGROUND厂房和场地YES是NO否1.Aregroundslitter-freeandisgrassproperlycut?场地是否无垃圾？草是否被合适割除？2.Isdrainageadequate?排水是否足够？3.Areareasdust-free?厂区是否无灰尘？4.Istheresufficientspacetoallowadequatesanitarypractices?是否有足够空间用于清洁作业？5.Arefloors,walls,andceilingsconstructedtoallowadequatecleaningandrepair?地板，墙和天花板的构造是否允许被充分清洁和修理？6.Arefixtures,ducts,andoverheadpipesinstalledtopreventdrippageintoproductandmaterials?是否有吊顶管路等装置来防止凝聚滴水污染产品和材料？7.Areaislesbetweenequipmentandwallsunobstructed?设备与墙之间是否畅通无阻？8.Areprocessingareasarrangedtopreventcontamination?作业区是否有防污染措施？9.Islightingadequatethroughout,andaresafetyfixturesusedinprocessingandwarehousingareas?整个厂区是否照明足够？作业和仓库区域是否有安全装置？10.Isthereadequateprotection(screening)againstbirds,animals,andvermin?是否有足够的保护措施来防止鸟，鼠和虫等？11.Isventilationadequate?通风是否足够？GENERALMANUFACTURINGCHECKLIST一般制造检查表3.0SANITARYFACILITIESANDCONTROLS清洁设施和控制YES是NO否1.Iswatersupplyadequateinquality,quantity,andtemperatureinareaswhereneeded?在用水区域，其水供应在质，量，和温度方面是否足够？2.Isthesewagedisposalsystemadequate?排污水系统是否足够？3.Isplumbingofadequatesizetocarrysufficientwatertoallrequiredlocation?供水管径是否足够匹配需水量？4.Isplumbingadequatetoconveysewageawayfromplant?排污水管径是否足够匹配排水量？5.Isplumbingofadequatesizeanddesigntopreventanunsanitarycondition?管径在设计上是否充分考虑了防止不清洁因素？6.Isthereadequatedrainagewhereneeded?需要排水的地方其排能是否足够？7.Aretoiletsproperlylocated,designed,sanitary,andadequatelyequipped?厕所在位置设计，清洁和设施配置是否合适？8.Aretoiletroomdoorsself-closing,anddonotopentoprocessingareas?厕所门是否自动关闭？其门不能朝向车间。9.Arehand-washingsignspostedintoiletfacilities?厕所内是否标示洗手？10.Areadequateandconvenienthand-washingfacilitieslocatedinappropriatelocationsandproperlyfurnished?厕所内洗手设施是否装备合理，方便，足够？其位置是否合适？11.Isrubbishdisposedofproperly?垃圾处置是否合适？GENERALMANUFACTURINGCHECKLIST一般制造检查表4.0SANITARYOPERATIONS清洁运作YES是NO否1.Generalmaintenance:Arephysicalfacilitiesmaintainedingoodrepairandsanitarycondition?一般维护：设备是否处于良好维护和清洁状态？2.Arecleaningoperationsperformedsafelyandarechemicalsusedeffectively？清洁作业是否安全？化学品是否有效使用？3.Areeffectivemeasurestakenforcontrolofanimals,birds,andvermin?是否采取了有效措施来防止鼠，鸟和虫？4.Arepesticideslabeledforuseinagoodplant,andareusedproperly？杀虫剂标签说明是否用于厂房？使用是否合适？5.Arepesticidesstoredawayfromproducts,productcontainers,andotherchemicals?杀虫剂是否与产品，包装物和其它化学品分开？6.Areproductcontactsurfacesofequipmentandutensilscleanedandsanitizedonscheduleusingadequatemethods？与产品接触的设备和器具表面是否获得定期清洗消毒？方法是否正确？7.Wherenecessary,areproductcontactsurfacescleanedandsanitizedpriortosuefollowinganinterruption？在必要场合，如生产过程被意外中断后，根据要求，与产品接触的设备和器具表面是否获得定期清洗消毒？8.Aresurfaceswhichdonotcomeincontactwithproductcleanedonscheduleusingadequatemethods?不与产品接触的设备和器具表面是否获得定期清洁？方法是否正确？9.Iscleanedandsanitizedequipmentproperlystored？清洗消毒后的设备是否被合适存放？10.Areequipmentandutensilsmadeofpropermaterialsandofsanitarydesigntofacilitatecleaningandpropermaintenance?11.Areequipmentandutensilsmechanicallyfunctional?设备和器具是否具有机械功能？（指搬运时的提手）GENERALMANUFACTURINGCHECKLIST全面制造检查表5.0PROSESSANDCONTROLS过程与控制YES是NO否1.Isoverallsanitaryresponsibilityassignedtooneindividual?所有卫生职责是否落实到个人？2.Arewarehouseandstockroomst