食品加工行业审核检查表.docx

食品加工行业审核检查表.docx

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食品加工行业审核检查表

本模块作为审核指南，完成模块中内审的考核以确定被审公司是否符合要求

1）Questionnaire:

Yes

Div

No

贮存区是个专区吗，出入受控吗

GMP范围涵盖了这一块吗

2）ReferenceStandardsList:

BeverageOperationsManual

BO-RQ-020

Concentrates&Bev.Bases–Storage&HandlingRequirem.

BO-RQ-200

GoodManufacturingPractices–DesignCriteria

BO-RQ-046

Concentrates&BeverageBases–BulkTankerRequirements

BO-RQ-205

GoodManufacturingPractices–BulkStorageFacilities

BO-RQ-910

Purchasing

BO-RQ-570

PowderDryMixManufacturing

TCCQSupdatesarecapturedtillDecember15,2005

3）SpecificationsandRequirementsSummary:

Specifications/Requirements

Concentrate/BeverageBase:

1

DoestheplantfollowallrequirementsonthestorageandhandlingconditionsofConcentratesandBeverageBases?

贮存和处理符合要求吗

Alarmishighlyrecommended

高度推荐警设备

Inmostcases,theConcentrateandBeverageBasepackagelabelswillcontainstorageconditions（temperature）andUseBeforeDates.Inthesecases,thissupersedesthespecificconditionslistedbelow-right.

大多数情况下，浓缩液主剂标签内容有贮存条件，使用日期，在这种情况下：

要求特殊的贮存条件列于右下角

ConcentrateandBeverageBasepackagesaretobesealedatalltimes.

浓缩液和主剂一直是密封的

BO-RQ-020

∙DocumentedproceduretobeavailableonthestorageandhandlingofConcentrateandBeverageBase.

∙要有主剂贮存与处理的的文件

∙Continuousmonitoringofstoragetemperaturewithrecordingdevicesoralarms.

∙对贮存区要连续温度监控，并要有记录或是报警

∙Trackingsystemimplementedtorecordlotnumbersofallincomingmaterialsastheyarereceived

∙按追溯要求，当接受来料时要记录下批号

∙SOPinplacetoexecuteFEFO（FirstExpireFirstOut）

∙有SOP规定执行FEFO

∙Storageconditionsindicatedonthecontainerorprintedonthelabelarefollowed.Ifnotindicated,CompanyDivisiontechnicaliscontactedforguidanceandcorrectiveaction.

∙贮存条件显示于容器上或是打印在随行的标签上，如没有，则公司技术部与之联系采取纠正措施。

oNon-refrigerated（ambient）:

11Cto30C（mustnotexceed30C）

o室温：

11Cto30C，不能超过30C

oNon-refrigerated（cool）:

11Cto20C

o清凉1Cto20C

oRefrigerated（cold）:

4Cto10C

o冷4Cto10C

oChilled:

0Cto4C

o冻：

0Cto4C

oDeep-frozen:

-20Cto-16C;targetis-18C

o深冻-20Cto-16C

∙ConcentrateorBeveragebasesbeyondtheexpirationdateorBestbeforedateprintedonthecontainerarenotused.Ifnotindicated,CompanyDivisiontechnicaliscontactedforguidanceandcorrectiveaction.

∙主剂、浓缩液、和有效期或最佳使用期等内容和贮存条件显示于容器上或是打印在随行的标签上，如没有，则公司技术部与之联系采取纠正措施。

∙RefrigeratedandfrozenBeveragebasesthatarestoredatambientarestoredinsuchconditionsforamaximumof2daysbeforeuse

∙在冻库中了取出主剂至室温区最长不超过2天

∙BulkcontainersofConcentrateorBevBasearenottobesplit

∙大容器的浓缩液和主剂不能拆分

∙ConcentrateandBeverageBasenottobesenttootherplantsunlessDivisionapproved.

没有公司的许可，浓缩液不能运于其余公司

2

DoestheplantstoretheConcentrateandBeverageBaseinadedicated,separateareawithcontrolledaccess?

贮存区是个专区吗，出入受控吗

BO-RQ-020/BO-RQ-200

∙Storedinadedicatedareawithaccessrestrictedtoauthorizedpersonnelonly.

∙贮存于专区，仅由专人进出。

∙Separatelyfromothernon-foodmaterials.

与非食品类分开

3

AreGMPissuescoveredforthestorageofConcentrate&Bev.Base?

GMP范围涵盖了这一块吗

Onemustbeabletowalkandcleanbetweenpalletsandwalls.

BO-RQ-200

∙Nopossibilitiesforcontaminationordeteriorationofquality

∙没有被污染或变质的可能

∙Easycleanablefloors/cleanarea/adequatelighting.

∙地板易清洁/清洁区/充足灯光

∙Allpalletrowsandpalletrackingawayfromthewalls

∙所有的托板排列不能靠墙

4

AreallBulkStoragerelatedissuescovered（ifapplicable）?

大宗贮存问题考虑到了吗

BO-RQ-046

∙Visualinspectionofreceivingload

∙接受装运的目检

∙Recordshippingtemperature

∙运输的记录

∙Agitatethebulktankerloadtohomogeneitybeforeunloading

∙在卸料前的搅拌均匀

∙Agitationtimeis1hour

∙搅拌时间1个小时

∙Visualinspectionofstoragetankforcleanliness/goodcondition

∙目检贮存缸的卫生

∙Remnants（leftovers）tobestoredincleancontainers（sealed）andtobeaddedtonextbatch

∙残留贮于另一清洁容器内（密封）加入下一批。

∙Maintaintraceabilityofremnantsuse

∙保持残留使用的可追朔性

∙Emptybulktankerstobevisuallyinspected,cleaned&sanitized,closed&sealed

∙空罐须目检，清洁、消毒、关闭和密封

∙RecordsystemtoguaranteetraceabilityofBulkConcentrateandBeverageBasedeliveries.

∙记录要能保证大桶浓缩液和主剂运输的可追朔性

BO-RQ-205

∙Atleast2storagetanksavailableforeachConcentrateorBeverageBasepartreceivedinbulk

∙每次浓缩液和主剂接收时要保证有2个可用的贮缸

∙Loadcellswithaccuracyof±0.1%

∙装载单位精度为±0.1%

∙Agitatorswithautomatictimers

∙搅拌器有自动记时器

∙Alltanksandpipingfrom316stainlesssteel

∙缸和管所用的材料所用的是316不锈钢

∙In-linestrainerof30meshbeforestoragetank

∙通过30目的过滤进入贮缸

∙Allpartsofsystemtowithstandsteamorhotwaterforsanitation

所有的设备能承受高温杀菌和消毒

5

Doestheplantfollowalltherequirementsonpowderdrymixmanufacturing?

工厂粉剂生产符合求吗

Ifrelativehumidityandtemperatureexceedtheabovelimits,productionmaycontinueforupto30minutes.After30minutes,productremovedandplacedonHoldfordisposition.

如果湿度和温度不符合要求，生产只能持续３０分钟，３０分钟后的产品要放于隔离区处理。

Sampleretention:

shelf-lifeoftheproductplusonemonth

长于产品保持期一个月

BO-RQ-570

SugarHandlingandEquipment

糖处理和设备

∙SugarpreparedonsiteforpowderbeveragemanufacturingmeetstheCompanystandardsandlocalregulations

∙现场准备用于粉剂饮料的糖要符合公司要求与地方法规

∙SugardriersareprovidedwithHEPA-filteredairatnotlessthan108ºF（42ºC）toattainnomorethan0.25%moisture

∙糖干燥器所提供的空气温度不低于42ºC以确保湿度不高于0.25%

∙Sugarhandlingequipmentisprovidedwithmoisture-free,oil-freecompressedairsuitabletomaintainsugarmoisture<0.25%

∙用于提供给糖处理设备的空压机的气体是去湿、除油，以保证其湿度不高于0.25%

∙Sugarstorageisprovidedwithafilteredventandamanholetofacilitatecleaningandinspection

∙糖贮设备要有过滤通风口和入口以便清洁和检查

Particlesizedistributionforingredientsandproduct

用于主份和产品粒子尺寸。

∙Rawmaterialsizedistributioniscontrolled.WhenMMIspecs,arenotprovided,thefollowingparametersareused;

原料尺寸配置已受控，MMI没有相关要求时则用以下参数

%%weight%weight%weight

compositionretainedbyretainedbyretainedby

inproductmesh>100mesh35-80mesh25-30

组分含量过滤后含量过滤后含量过滤后含量

Sugar93%4%orless86%ormore10%ormore

糖

Citricacid2%1%orless98.3%ormore0.1%ormore

柠檬酸

Product100%3%orless93%ormore4%ormore

产品

EmptyCans空罐

∙Anon-glassmirrorisinstalledabovecande-palletizersandpositionedforinspectionoftheinteriorsurfacesofcans

∙安装非玻璃制镜于拆垛机顶以监控罐内表面

∙Emptycansareblownoutwithclean,dry,oil-freeairtoremovedustanddebris.Equipmentisdesignedandpositionedtocontroldustanddebrisattheblower.

∙用干燥、除油以的空气以吹尽内部尘埃，设备的设计与定位以便控制吹风机的尘埃和碎片

IngredientBlends主份混合

∙Blend/mixtimeproceduresarevalidated

∙混合时间合理

∙Ingredientspassthrougha¾-inchstainlesssteelscreenbeforebeingaddedtothemixer

∙通风¾-inch过滤网加入到混合器

∙Ingredientsareblendeduntiluniform,andpriortofilling

∙灌注前不停搅拌均匀

∙,uniformityisconfirmedbytesting.

∙检测是否搅拌均匀

∙Blendedmixtransferredtothefillerpassesthrougha10-meshscreenandarareearth,in-linemagnetormetalrejectionsystem

∙经过10目在线筛和磁铁送往灌注机

∙Weighingdevicesaccuracyisbetterthan0.50%overtheentireusablerange.

∙称量装置的精确度要好于0.50%

DryMixproducts

∙Notblendedorpackagedinornearareaswherethefollowingproductsoringredientsareproducedorhandled,orsharedustcollectionandventilationsystemswiththem.

∙不能在有以下产品或主份区域搅拌和包装，或是共用空气吸尘或通风装置

-microbiologicallysensitive

-微生物敏感

-allergens

-过敏源

-pungentproductsoringredients

-有刺激性气味的产品或是主份

Climate-controlareas环境控制区域

∙Mixingandfillingareasareclimate-controlledanduselessotherwisespecifiedintheMMI,mustmeetthefollowingparameters

∙配料与灌注区是控制区，如果没在MMI没有特别说明，则必须符合以下要求

Productandpackagetesting

生产与包装测试：

∙Productsamplesaretakenatstart-upandaftereachchange-overfortestingaccordingtoMMIandforsampleretention

∙产品开机取样和根据ＭＭＩ每个改变的测试和留样。

∙Packagespecificationsfornetcontent,tamperevidence,integrityanddatecodingisroutinelychecked

∙包装标准要求包括净含量、防盗环、完整性、喷码进行日常检测

Rework

返工

∙Batchingrecordsaremaintainedfor2yearsminimumandmustinclude:

∙批记录至少保存２年，必须包括以下内容；

-dateandbatchnumber

-日期和批号

-Quantity

-数量

-Product

-产品

-traceabiltytooriginalsource

-源头可追溯性

-verificationandinspectionchecks

-验证检验记录

-namesandinitials

-名字和

Cleaningandsanitation

清洁与消毒

∙Cleaningroutinesandproceduresareinplaceforseals,crevices,cornersanddischargepoints

∙对密封处、缝隙、角落、排放口的日常清洁要有程序

∙Blendingandmixingequipmentareleftemptyattheendofproductionrunsandcleaneddaily

∙配料在生产结束时要排空并进行日常清洁。

∙Equipmentinspecteddailyforo-rings,valves,gaskets,blenderseals,andbladealignmentinribbonblenders

∙要对设备的胶圈进行日常检查

∙Fillingandpackageequipmentarecleaneddailyafteruse.In-linescreensandmagnetsdisassembledandinspecteddaily.

灌注机和包装设备用后检查，在线过滤网和磁铁拆下检查

Note:

ForSystems,CertificationandFollow-Upaudits,usethisprocessassessmenttoverifythestatusofimplementationandeffectivenessforthefollowingSystemElements:

-DocumentManagement

-RecordKeeping

-ProcessIntegrity

-Calibratio

-