Mapping&MonitoringforControlledEnvironments

HowtoMapaWarehouse

BruceMcDuffee SteveChenal

WebinarPresenters&HumidityExperts

Agenda&Takeaways

Agenda• Regulations&GuidanceOverview• Step1– SpaceAssessment• Step2– PreparetheProtocol• Step3– ConducttheMapping• Step4– PreparetheReport• Summary&Questions

Takeaways• Understandthehighlevelprocess• Learnwhatquestionsyoushouldbeasking

Regulations&Guidance

RegulationandGuidanceUSP(UnitedStatesPharmacopeia)

• USPChapter1079– GoodStorageandDistributionPractices• describesgoodstorageanddistributionpracticestoensurethatdrugproductsreachtheenduser(practitionersandpatient/consumers)withqualityintact.

“Drugproductstorageareasarerequiredtomaintaintheproducttemperaturebetweenthelimitsasdefinedontheproductlabel.“

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RegulationandGuidanceUSP(cont.)

• USPChapter1118MonitoringDevices– Time,Temperature,andHumidity

• Providesbackgroundonthescienceandtechnologyoftemperatureandhumiditymonitoring

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• ECGuidelines- GoodDistributionPracticeofmedicinalproductsforhumanuse(5November2013)

• “Suitableequipmentandproceduresshouldbeinplacetochecktheenvironmentwheremedicinalproductsarestored.Environmentalfactorstobeconsideredincludetemperature,light,humidityandcleanlinessofthepremises.• Aninitialtemperaturemappingexerciseshouldbecarriedoutonthestorageareabeforeuse,underrepresentativeconditions.”7

RegulationandGuidanceEU

RegulationandGuidanceWHO

• WorldHealthOrganization(WHO)• TechnicalReportSeries,No.961,2011• Supplement8- Annex9:Modelguidanceforthestorageandtransportoftimeandtemperature-sensitivepharmaceuticalproducts(May2015)

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RegulationandGuidanceFDA

• FoodandDrugAdministration• “Storageofdrugproductsunderappropriateconditionsoftemperature,humidity,andlightsothattheidentity,strength,quality,andpurityofthedrugproductsarenotaffected.”

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SpaceAssessment

SpaceAssessment

•WhattypeofHVACispresent?• Heating• Airconditioning

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SpaceAssessment

• HVACducts• Lighting• Rackheights

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• Windows• Doorways• Exteriorwalls• Anythingthatmaycreateheat/coolzones• compressor• fans• etc.

Potentialhighvarianceareas:

SpaceAssessmentandBegintoPreparetheProtocol

• Considerthemappingreportdetailsbefore startingthemapping.

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PreparetheProtocol

PreparetheProtocol

• Manyroommappingsfailduetoapoorlypreparedprotocol

• Keeptheprotocolsimpleandtargetedaspossible

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PreparetheProtocolThemappingprotocolshouldcontainthefollowingsections:a. Approvalpageandchangecontrol

historyb. Acronymsandglossary

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PreparetheProtocol

c. Descriptionandrationaled. Scopee. Objectives

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PreparetheProtocol

f. Methodologyg. Mappingreporttemplateh. Annexesasneeded

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PreparetheProtocol

• SpecialCalculations• MKTCalculation• asimplifiedwayofexpressingtheoveralleffect oftemperature fluctuationsduringstorage

• HighLowData• MeanTemperatures• Leveragereportingfromthedatacollectionsoftwaretoenhancethefinalreport

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Comments&Questions

Pleasetypeyourquestionsintothechatboxatthelowerleftportionofyourscreen.

ConducttheMapping

ConducttheMapping

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• Followthedefinedmappingprotocol

• Placeanddocument theplacementofloggers

• Ensurethateachloggercanbeidentified

ConducttheMapping

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• Ensurethatloggermemorywillbeavailablefortheentirelengthofthemapping

• Ensurethattheloggersareactiveandlogging

• Checkdataloggerbatterylevel

PreparetheMappingReport

PreparetheMappingReport

Themappingreportshouldincludethefollowingsections:

a. Introductionb. Summaryc. Conclusionsandrecommendationsd. Reportannexes

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PreparetheMappingReport[cont.]

d. Reportannexesincluding:• thesitesurvey,showingloggerlocations• therawdata• spreadsheetdataandrelatedtemperaturegraphsforeveryEDLMusedinthemappingexercise• rawresultsofthedataanalysis,includinghotandcoldspots• keydocumentsanyothersupportingmaterial• deviationreports,includingcorrectiveandpreventiveactionforms,ifrequired:thismayincludearecommendationforpartialortotalre-mapping• calibrationcertificatesforallloggersused

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SomeNotesabouttheMappingReport

• Again:Leveragereportingfromthedatacollectionsoftwaretoenhancethefinalreport• Includemean,minimumandmaximumdata(hotandcoldspots)

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MoreNotesabouttheMappingReport

• Thereportshouldincludeanyanomaliesordeviations• Recommendationsshouldbeincludedforanyrequiredchanges

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SummaryandTakeaways

• Regulations&GuidanceOverview• Step1– SpaceAssessment• Step2– PreparetheProtocol• Step3– ConducttheMapping• Step4– PreparetheReport

Comments&Questions

Pleasetypeyourquestionsintothechatboxatthelowerleftportionofyourscreen.

Rotronic Academy

• ResourcesforcGMPmapping• Resourcesforenvironmentalmonitoring

www.rotronic-usa.com/academy

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