25/09/2016

www.gmpmanual.com/docs/h06_fm_018.html

8.Documentation
8.1Thedocumentationrequiredforthetransferprojectitselfiswideranging.Examplesofdocumentationcommonly
requiredaresummarizedinFigureH.62.
8.2Thedocumentedevidencethatthetransferoftechnologyhasbeenconsideredsuccessfulshouldbeformalizedand
statedinatechnologytransfersummaryreport.Thatreportshouldsummarizethescopeofthetransfer,thecritical
parametersasobtainedintheSUandRU(preferablyinatabulatedformat)andthefinalconclusionsofthetransfer.
Possiblediscrepanciesshouldbelistedandappropriateactions,whereneeded,takentoresolvethem.
FigureH.62Examplesofdocumentationfortransferoftechnology(TOT)
DQ,designqualificationIQ,installationqualificationOQ,operationalqualificationAPI,activepharmaceutical
ingredientSOPs,standardoperatingproceduresRU,receivingunit.

Keytask
Projectdefinition

Documentationprovided
bySU

Transferdocumentation

Projectplanandqualityplan(whereseparate
documents),protocol,riskassessments,gap
analysis

Projectimplementationplan
TOTprotocol

Plansandlayoutoffacility,buildings(construction,
finish)
Qualificationstatus(DQ,IQ,OQ)andreports

SidebysidecomparisonwithRUfacility
andbuildingsgapanalysis
Qualificationprotocolandreport

Health&Safety
assessment

Productspecificwastemanagementplans

Skillsetanalysisand
training

SOPsandtrainingdocumentation(productspecific
operations,analysis,testing)

Trainingprotocols,assessmentresults

Analyticalmethod
transfer

Analyticalmethodspecificationsandvalidation,
includinginprocessqualitycontrol

Analyticalmethodstransferprotocoland
report

Startingmaterial
evaluation

SpecificationsandadditionalinformationonAPIs,
excipients

Equipmentselection
andtransfer

Inventorylistofallequipmentandsystems,
includingmakes,models,qualificationstatus(IQ,
OQ,PQ)

SidebysidecomparisonwithRU
equipment(makes,models,qualification
status)

Drawings,manuals,logs,SOPs(e.g.setup,
operation,cleaning,maintenance,calibration,
storage)

Gapanalysis

Referencebatches(clinical,dossier,biobatches)

HistoryofprocessdevelopmentatRU

Developmentreport(manufacturingprocess
rationale)

ExperiencesatRUshouldberecorded
forfuturereference

Historyofcriticalanalyticaldata

Provisionalbatchmanufacturing
document(RUtodevelop)

Qualityagreement
Facilityassessment

Processtransfer:
manufacturingand
packaging

Contingencyplans

Rationaleforspecifications
Changecontroldocumentation
Criticalmanufacturingprocessparameters

Qualificationandvalidationprotocol
andreport

Provisionalbatchpackagingdocument
(RUtodevelop)

Processvalidationreports

DescriptionofprocessatRU(narrative,
processmap,flowchart)

Drugmasterfile

Processvalidationprotocolandreport

APIvalidationstatusandreport(s)
Productstabilitydata
Currentmasterbatchmanufacturingandpackaging
records
Listofallbatchesproduced
Deviationreports
http://www.gmpmanual.com/docs/h06_fm_018.html

1/2

25/09/2016

Deviationreports

www.gmpmanual.com/docs/h06_fm_018.html

Investigations,complaints,recalls
Annualproductreview
Cleaning

Cleaningvalidation,including:
Solubilityinformation
therapeuticdoses
category(toxicology)

ProductandsitespecificcleaningSOPs
atRU
Cleaningvalidationprotocoland
report

existingcleaningSOPs
validationreportschemicalandmicro
agentsused
recoverystudy

http://www.gmpmanual.com/docs/h06_fm_018.html

2/2