5 sự thật bị hiểu lầm về giám sát kho và phòng lạnh
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Warehouse and cold room monitoring is important for regulatory compliance. Temperature mapping identifies hot and cold spots to ensure proper temperature control. It should be conducted during commissioning, empty, and full capacity. Monitoring systems provide independent data for audits while building management focuses on control. Sensors must be calibrated regularly to ensure accurate measurements. The type of facility impacts mapping needs based on ambient exposure. Qualification proves equipment is fit for use while validation confirms processes achieve expected results.
5 sự thật bị hiểu lầm về giám sát kho và phòng lạnh
- 2. WarehouseandColdRoomMonitoring: The Cold Chain Challenge The pandemic caused by COVID-19 highlighted the weak- nesses of the global cold supply chain infrastructure and theimportanceofmaintaininganuninterruptedflowof medicines and healthcare products. Cold logistics guarantees the storage, transport, and distribution of your products, such as vaccines andother medication,atthepropertemperaturetoensureintegrity andquality.Traditionalsupplychainlogisticsaimtoreduce all tasks to one; by adding a cold chain we complicate its management.1 It is critical for warehouse managers, operations and logisticsprofessionalslikeyoutounderstandtemperature control, in addition to how and why it must be maintained throughout the entire manufacturing process. From the storageofAPIs(activepharmaceuticalingredients)to production, storage and distribution,temperature-sensitive products must be kept safe through proper management of product stability budgets. If the temperature of pharma- ceuticalsandvaccinesarenotkeptincheckthroughoutthe coldsupplychain,theycanloseefficacyor,insomecases, transform into a completely different substance. As a result, productqualityandpatientsafetyarecompromised.This quick guidewillhelpyouunderstandfiveimportant misun- derstood aspects of warehouse and cold storage monitoring and controlling temperature to ensure regulatory compli- ance throughGoodDistributionPractice(GDP)andGood Manufacturing Practice(GMP).
- 3. 1 | Warehouses and Cold Rooms Need to Be Qualified Ifyouworkinbiopharma/pharmaorlifescience logistics, youshouldcomplywiththegood manufacturingpractices (GMP) and good distribution practices (GDP).This means youmust produce,handle,store,andtransportyourprod- ucts inqualifiedfacilitieswithqualifiedequipmentusing validated processes. Thequalificationforfacilitiesandequipmentisthe final series of inspections and tests to ensure that critical requirements necessary for related product quality are sat- isfiedandthatthedocumentsand proceduresnecessaryto properly operate and maintain the system are inplace. Qualificationistheprocessofprovingthatfacilitiesand equipmentworkproperlytodeliverqualityresults,which fulfil the intended purpose in accordance to the user requirement specification (URS). Apart from regulatory complianceandstipulation,qualificationiskeytoensuring product quality, continuity of supply and a healthy, effective outcome for consumers and patients. Documented Proof A qualification should follow Good Documentation Practice (GDocP) and include clear document naming, versioning, change history and document ownership. Furthermore, a proofisonlypossible with evidence,whichmeans that atestplanandclearlyidentifiableandreproducibletest results must exist. 1 Solistica.com
- 4. 3 URS User Requirement Specification Fit, form and function for the temperature range you need. PQ Performance Qualification Performance Test: Allstockedupandmonitored? We prove it works in winter and summer. OQ MAPPING MQP Master Qualification Plan Definitionofstrategy, responsibilitiesand requirements for qualification. RA Risk Assessment Assessing risks means avoiding risks. We know exactly what tolook for. Operational Qualification Functional Test: Readytogo–let‘sfindthose hot and coldspots. DQ Design Qualification Webringyourdocuments intoshapeandensureyou havealltheevidencerequired. IQ Installation Qualification Reality Check: Documented proof that everything hasbeenbuiltandinstalledaccording to specification. Planning Construction Test Using Intended Purpose Stated Clear requirements must be documented and answer importantquestions,suchas:whatistheequipmentinthe qualificationprocesssupposedtodo?Bydefiningthein- tention, one automatically excludes all other non-intended purposes and effects and minimizes risks. According to the GAMP® 5 V model framework, the master qualificationplan(MQP)isdevelopedtodefinetheseriesof actions and analyses including functional specification (FS), design qualification (DQ), risk assessments, implementa- tion, installation qualification (IQ), operational qualification (OQ),andperformancequalification(PQ).Theresultofthe qualificationprocessiscaptured,recorded,andapproved withinaqualificationsummaryreport(QSR).Aseriesof tests should be adapted at each stage to ensure that any issues identified are completely resolved. 2 |Temperature Mapping is Mandatory for Compliance A temperature mapping study is a method of measuring and documentingthetemperaturedistributionwithina chamber bylocating thehottestandcoldestspot.Accord- ingtothe WorldHealthOrganization(WHO),“mappingmay alsobeused toidentifyzones where remedialactionneeds tobetaken;for examplebyalteringexistingairdistribution to eliminate hot and cold spots.” A mapping study takes placeforadefinedtime period,typicallyafewdaysor weeks,andmonitors temperature invariousdefined loca- tionsinsideaspace(e.g. refrigerator,freezer,warehouse, cold storage room,box or container)forming themapping grid. The mapping grid follows two principles:
- 5. 4 Advantages of Warehouse Monitoring with an Independent System: Calibrationofthemonitoringsensorscanbecarriedout without impacting the system operation. Theindependentsystembecomesthe“qualitysystemof record.” Thedatacanbeusedtoprovidecontinuousverification of acceptable system performance. 1. A three-dimensional network of mapping points with consistentintervalsinthe x,yandz axes. ISPE orWHO definestheexpecteddistance between themapping points. 2.Additionalmapping pointsbeing theexpectedhot and cold spot (which could be near the air outlet, door,seal or wall). Followingthemappingplan(floorplan),the calibrated mapping temperature and/or humidity data loggers are con- figured,clearlylabeled,and placedatthedefinedmapping positions.Afterthe definedtimeperiod,allmappingloggers are collected,themeasurementcurves areanalyzedand thehottestandcoldestspotintheroomareevaluated. The mapping is successful if no temperature outside the required temperaturerangehasbeenfound.The hottestandcoldest spotsareobvious placesto install sensorsofthemonitoring solution,sinceatemperature excursionatthosespotswould bemostcriticalfirst andthereforemeasuredfirst.
- 6. 5 The International Society of Pharmaceutical Engineers (ISPE)documentationprovidesclearguidanceongood practices for the mapping of controlled temperature chambers,warehousesandrefrigeratedstorageareasused tostorerawmaterialoractivepharmaceuticalingredients (APIs),workinprogressorfinishedproducts.Itisintended tobeusedwhenspecifying,commissioningandqualifica- tion activities.2 Temperature mapping is also used to confirm that the systemisoperatingtomeetspecifications.Forexample,it can help you determine if the temperature range within the unitisacceptable. Itisa standard practiceinthepharma- ceutical industry to provide monitoring with an indepen- dent system. Mapping results may be used to define the ideal number andlocation ofmonitoring sensors for a warehouse, cold room, orchamber. When Should Temperature Mapping Be Performed? Temperature mapping a warehouse should start as early as possible during commissioning and qualification. This al- lowstheearlydetectionandresolutionofanyperformance issues.Italso allowspotentialoperational constraintsto beidentifiedanddiscussed withusers, todetermine ifthe constraints are acceptable or require resolution. Ideally, temperature mapping should be conducted when the facili- tyisemptyandalsoduringatimewhenitisatfullcapacity. Forwarehousesinparticular,mappingtemperaturesduring months when outside temperatures are usually at extremes (summerandwinter) isalso highly recommended. Systemsthatsupportthewarehouseheating,ventilation, and air conditioning (HVAC)should be commissioned prior to temperature mapping of the warehouse, to helpensure complete and representative testing. Alternatively, the operatingstateofsupportsystems shouldbeunderstood to allowevaluationofsubsystemoperationalissuesthatmay affecttestresults.Sub-systemoperationalissuesshouldbe monitoredindependentlyincaseinvestigationisrequired.3 °C °C °C °C °C °C °C °C Mapping and Qualifying a Freezer Farm in a Warehouse More and more 3PLs are building warehouses and large fa- cilities to house numerous refrigerators, freezers, ultra-low (ULT) freezers and cyrostorage containers. Therefore, qual- ifications are typically done as a so-called “fleet” or “farm” qualification, which is performed as follows: 1. Clusterthefleetoffreezersintohomogeneousgroups, for exampleclustered by samesupplier,same model and samesize. 2. ForeachgroupapplytheGAMP®5VModel and workout: User Requirement Specification: document tempera- ture range and description of application. Risk Analysis: evaluate placement, power supply and operationalaspectslikefrequencyandlengthsofdoor opening, loading and cleaning patterns. DesignSpecification:Foreachclusteroffreezers,de- fine exact purchased model and installationinstructions (avoidblockageofairflowcompressor,powersupply). Operational Qualification: One freezer from each clus- ter is mapped in detail following WHO guidelines in an empty status. 3. Next,thedesignqualificationcanbeperformedforone freezer(perclustergroup)bysimplycheckingifitisthe rightmodel, and ensuring theairflow and power supply comply with the specifications. 4. Sinceonefreezerperclustergrouphasalreadybeen mapped,itisnowpossible(fortheremaining freezers ofthesamegroup) to skipthedryrunqualification and conductaperformancequalification(mappingofthefull freezer) directly during normal operation. Of course, the mapping should be performed with data loggers that are calibrated and compliant.
- 7. 6 Self Service Temperature Mapping Kits Save Cost and Ensure Compliance Do-It-Yourselftemperaturemappingkitscansavetime, eliminate expensive onsite travel costs with consultants andstillhelpyougainrequiredcompliancedocumentation. Thesekitstypicallycomewithpreconfigureddataloggers, stepbystepplacementinstructionsanddownloadable mapping protocol. Mapping kits have been developed for refrigerators, climate cabinets, incubators, smaller storage roomsandULTfreezerswiththefollowingspecifications: Equipment mapping kits: Ideal for small standalone equipment≤2m3 (70ft3 )suchasrefrigerators,climate cabinets and incubators. Room mapping kits: Ideal for large standaloneequipment between 2 m3 to 20 m3 (70 ft3 to700 ft3 ) and small walk in rooms 18 m × 18 m (60 ft × 60 ft) ULT freezer mapping kits: Ideal for upright fourchamber ultra-lowtemperaturefreezersinGxPstorageareas Therearenumerousbenefitstothisapproach and some of the advantages include: Simple implementation: Order the kit, place mapping data loggers and create the report Step-by-stepguide:Reportprovidesvaluable informationonGxPcomplianceandguidesyou through the process GxP compliance: Mapping data loggers are GAMP5 validated.MappingisWHOandISPEcompliant Evaluated by a GxP specialist: Results of the mappingstudyareevaluatedbyGxPengineers Flexibility: A separate kit for each room/piece of equipment and temperature range Peace of mind: Trusted compliance and a clear conscience before your next audit 3 | Building Management Solutions and Environmental Monitoring Systems Are Not theSame Inanyproductionenvironmentandinmanywarehouses, state-of-the-artbuildingmanagementsolutions(BMS),or buildingautomationsystems(BAS),areinstalledtoconduct measurements of temperature and environmental data (like humidity),andgivecommandstoHVACsystems,power supply, fire safety systems, electrical and plumbing systems, security systems and more. Environmental monitoring solutions,bydesign,provideredundancyandoperatefully independent from any control mechanism. Although an implementation of “dashboard” solutions can bring all of thesesystemstogetherandprovideonecomprehensive viewofthedataforfacilities,thevalidatedindependence ofanenvironmental monitoring solution isstill animport- ant requirement to comply with GDP and GMP guidelines. Environmental monitoring solutions provide visibility to datathatallowsfor reportingandassessment, easy access todatafortraceabilityandaudits,andcompliancewithFDA 21 CFR Part 11. Building Management Solution Monitoring Solution Sensor Sensor Monitoring Software Alarm Controlling Report Monitoring Air Conditioning Controlling Software
- 8. 7 4 | Validation vs. Qualification: What’s the Difference? Manypeopleoftenconfusethesetermsontheirpathto monitoringwarehousesandcoldstoragefacilitiestoGMP andGDPcompliance.However,thedifferenceiseasy to rememberonceyouunderstandthe definitions. Validation Defined According to GMP/GDPguidelines, validation isa method ofcheckingifaprocessoractivityhastheexpectedresult. Validationisthereforeabouttaking a closer lookata com- pleteprocess.TheGxPrulesdefinethatallqualityrelevant processesmustbevalidated.Thefirstpartofthevalidation istodefinetheexpectedresults;thesecondpartistoverify anddocumentthattheprocessdeliverstheexpectedre- sult.Forexample,tostoreproductsinawarehouse,youof courseneedthewarehousefacilityitself,butyoualsoneed employees,whicharequalifiedtodotheirjob,systems to support your processes, and you may need addition- al equipment to ensure the product is stored according to itsneeds.Allofthesethingsmentioned abovewould requirevalidation.However,validationisonlypossibleifall quality-relevant elements in your supply chain are qualified upfront.Examplesoftheseelementsmayinclude,butare notlimitedto,storagefacilities,coldrooms,containers, insulatedboxes,refrigeratedtrucks,vans,dataloggers, andsoftwareforevaluationandarchiving.Ifallofthese elementsarequalifiedaccordingtoEU-GMPGuideline, Annex 15,youcanbeginthevalidation oftheprocessusing all those elements. Qualification Defined Qualificationistheprocessofprovingthataroom,system, facility,transportcontainer,truckorsupplierfulfillsthe intendedpurpose.Inotherwords,ifapieceofequip- mentisusedinsomewaytoproduce,handle,storeor transport pharmaceutical products, a “qualification” must demonstratethattheequipmentisfitforthatpurpose. Forexample,ifawarehousemustmaintainatemperature rangeof2°Cto8°Cineveryarea,thequalificationcertifies thatthewarehouseisfitforpurposeandthatthefacility can indeed maintain a temperature range of 2 °C to 8 °C. Thequalificationalwaysstartswiththedefinitionofthe intendedpurposeandthencontinueswithanevaluation and documentation of whether the equipment, facility, etc., is suitable to fulfill the intended purpose. Sensor Calibration for Compliance Another important aspect that highlights the needs for an independentenvironmentalmonitoringsolutionissensor calibration.Thetemperatureandhumiditysensorsusedin many leading building automation systemstoday cannot be recalibrated. In order to maintain GDP and GMP com- pliance,sensorsarerequiredtoberecalibratedatprede- termined times. Recalibration plays a critical role to ensure that sensors and data loggers are performing as accurately andandaserror-freeaspossible.Sensorscan“drift”over timeresultingininaccuratemeasurement. Tip Asimplewaytorememberthedifference:whateveryou cantouch,youcanqualify.Everythingelseisvalidated. Qualification Validation Kalibrier Kalibrier- -zertifikat Calibratioznertifikat Certificate Calibration
- 9. 8 Type Description (typical) Temperature Range (typical) Implications on Qualification and Mapping Warehouse Large room/ hall with open space or high racks +15 °C to +25 °C +2 °C to +8 °C Warehousestypicallyhaveouterwallsdirectlyexposedtoambient conditionsandseasonaleffects.Insulationofthebuildingandthe absenceofwindowsandotheropeningsisvital.Sincewehave influencefromambientconditions,awinterandsummermapping will be necessary. Same applies for the loading dock. Cold Rooms Smaller room/ hall with open space or racks +2 °C to +8 °C –20 °C Coldroomsaretypicallyrooms inside a building andthewallshave no directexposuretoambientconditions andseasonaleffects.Of- ten there is no need for performing a separate winter and summer mapping. Other facilities and loading docks Smaller room with racks +15 °C to +25 °C +2 °C to +30 °C < +40 °C Thestored/handledproducts,therrequiredlabelconditionand therelengthsofstaywilldefinetheframeworkandcomplexityof the qualification and mapping. 5 | Not All Temperature Zones inWarehousesAreEqual It is important to understand that many warehouse and coldroomfacitilitiesaredesignedandengineeredtomain- tainmultipletemperaturezoneswithinthesamestructure. Beforeanappropriatetemperatureandhumiditymonitor- ingsolutionisspecified,itisimperativetounderstandwhat customers intend to store and the temperature control requirementsprovidedbythemanufacturer.Thesespecifi- cationswillguidethedecision-makingprocesstodetermine theappropriateallocationofspace,andwhatbespokesen- sorsandenvironmentalmonitoringdatagatheringdevices will be required. Qualifying and mapping warehouses, cold rooms and storagefacilitiesiscomplexbecausetheyarenotoff-the- shelfproductslikerefrigeratorsorfreezers.Althoughthey arebuiltwith standard components, they are engineered facilitieswithuniquedesigns,layouts,airflows,doorsand controlsystems.There aremany differenttypesofware- houses,coldroomsandstoragefacilities.Allrequireunique spaceandtemperaturezoneallocations,dependingon whatcustomers intendto storeinthem andspecifications providedbythemanufacturers.Allhaveamajorimplication onthequalificationandmappingstrategy,aswellasthe bespokesensorsandenvironmentaldatagatheringdevices. In Summary Temperature-controlledlogisticsandthegrowingneedfor globalcoldchainwarehouse,coldroomandstoragecapac- ity is not slowing down anytime soon. The rise of advanced therapiesandgrowingpipelineforpersonalizedmedicines willaccentuatethedemandforexcellence,regulatory compliance and resiliency in these supply chains. Careful planning and forging the right supply chain partnerships will be the keys to long-term success.
- 10. PRACTICAL GUIDE | 5 MISUNDERSTOOD FACTS ABOUT WAREHOUSE AND COLD ROOM MONITORING 8 This practical guide is part of the Warehouse & ColdRoomwebsitecontentforwarehouse managers,operationsandQAmanagers. Topics include warehouse and cold room qualificationandvalidation,temperaturezones and temperature mapping, and the difference between building management systems and environmental monitoringsystems.