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.

1. 5Misunderstood
Facts About
Warehouse
and ColdRoom
Monitoring

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.