Scribd
Upload
195 views2 pages

Docs h06 FM 018

The document discusses the documentation required for transferring technology between a sending unit (SU) and receiving unit (RU). It notes that the documentation is wide-ranging and provides examples of common documentation, including project plans, facility qualifications, training documentation, analytical method transfers, equipment information, process documentation, and cleaning validation documentation. It states that the transfer should be documented in a technology transfer summary report that summarizes the scope, critical parameters, and conclusions and notes any discrepancies or necessary actions.

Uploaded by

Archan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
195 views2 pages

Docs h06 FM 018

The document discusses the documentation required for transferring technology between a sending unit (SU) and receiving unit (RU). It notes that the documentation is wide-ranging and provides examples of common documentation, including project plans, facility qualifications, training documentation, analytical method transfers, equipment information, process documentation, and cleaning validation documentation. It states that the transfer should be documented in a technology transfer summary report that summarizes the scope, critical parameters, and conclusions and notes any discrepancies or necessary actions.

Uploaded by

Archan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 2

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

You might also like