Validation documents

Details explanation on validation documents like design qualification, installation qualification and operational qualifcation

2. Validationisaprocessofestablishingdocumentary evidence
demonstratingthataprocedure,process,oractivitycarriedoutin
productionortestingmaintainsthedesiredlevelofcomplianceatall
stages.
Qualificationisactionofprovingthatanypremises,systemsand
itemsofequipmentworkcorrectlyandactuallyleadtotheexpected
results.
DEFINITION

3. PURPOSE OF DOCUMENTATION
•Preventserrorsthatmayarisein
oralcommunication.
•Toobtainconsistent,reliable&
accuratedata
•Itprovidesassurancethatquality
relatedactivitiesarecarriedout
exactlythewaytheyhavebeen
plannedandapproved.
•Toachieveconformityandquality
improvement

4. •Designqualification(DQ)
•Installationqualification(IQ)
•Operationalqualification(OQ)
•PerformanceQualification(PQ)
WHAT DOES VALIDATION DOCUMENTS INCLUDE

5. VALIDATION MASTER PLAN
Allvalidationactivitiesareplannedusingthe‘VModel’approachas
followstoidentifytherelationshipbetweenthedevelopmentand
testingphasesoftheprojectensuringthatappropriatequality
assuranceandtestingtakesplacethroughouttheprojectlifecycle

6. VALIDATION MASTER PLAN

7. •UserRequirement Specifications(URS):defineswhatuser
wantsfromthesystemandmakessurethatrequirementismet
•FunctionalSpecifications:definesorcreatesadocumentinuser
understandableformatbasedonURS.
•DesignQualificationDQ:willverifytherequirementsoftheuser,
especiallyGMPrelevantrequirements,aremetbythesystem.
STEPS OF SYSTEM QUALIFICATION

8. Installation Qualification IQ: provides documented evidence that
the system, as installed or modified, comply with the approved design
and the manufacturers recommendations..
Operational Qualification (OQ) provides documented evidence that
the systems and sub-systems are capable of consistently operating
within established limits and tolerances.
Performance Qualification (PQ) is conducted to demonstrate
compliance with all requirements under actual process conditions.
STEPS OF SYSTEM QUALIFICATION

9. VALIDATION TIME LINE
Vendor’s
Site
Owner’s site
Before Purchase Before Use After Use
Structurally
Validated
Products
DQ
Functional Validation
Installation Operational
Qualification Qualification
Performance
Qualification
PQ
IQ OQ

10. THE 4 STEPS OF SYSTEM QUALIFICATION
Step 1: Design Qualification (DQ) will verify the requirements of the
user, especially GMP relevant requirements, are met by the system.
Step 2 :Installation Qualification (IQ) provides documented evidence
that the system, as installed or modified, comply with the approved design
and the manufacturers recommendations.
Step 3: Operational Qualification (OQ) provides documented evidence
that the systems and sub-systems are capable of consistently operating
within established limits and tolerances.
Step 4: Performance Qualification (PQ) is conducted to demonstrate
compliance with all requirements under actual process conditions.

11. •DesignQualification(DQ)definesthefunctionalandoperational
specificationsoftheequipment/system anddetailstheconscious
decisionsmadeintheselectionofthesupplier.
•DQ should ensure that equipment/system have all the necessary
functions and performance criteria that will enable them to be
successfully implemented for the intended application and to meet
user requirements.
DESIGN QUALIFICATION (DQ)

12. DESIGN QUALIFICATION (DQ)
The Design qualification includes documents i.e
•Datasheets
•DQprotocol
•Billofmaterial(BOM)
•Paneldocuments(I/Olist&writeup)
•Standardoperatingprocedure(SOP)
•Testreports&weldingprotocols
•Utility&sparepartspecification
•Pipingandinstrumentationdiagram(P&ID)

13. INSTALLATION QUALIFICATION (IQ)
•Installationqualification(IQ)istheprocessofcheckingthe
installation,toensurethattheequipmentmeetstheapproved
specificationandareinstalledcorrectly,andtoseehowthat
informationisrecorded.
•Thepurposeistoensurethatallaspectsofthefacilityorequipment
areinstalledcorrectlyandcomplywiththeoriginaldesign.
•Allofthecomponentsareidentifiedandcheckedagainstthe
manufacturer’scomponentlisting.
•Theworkingenvironmentconditionsaredocumentedandcheckedto
ensurethattheyaresuitablefortheoperationoftheequipment.

14. OPERATIONAL QUALIFICATION (OQ)
•Operationalqualification(OQ)istheprocessoftestingtoensure
thattheindividualandcombinedsystemsfunctiontomeetagreed
performancecriteriaandtocheckhowtheresultoftestingis
recorded.
•Thepurposeistoensurethatallthedynamicattributescomply
withtheoriginaldesign.
•Eachoftheequipmentfunctionarecheckedtoensurethatthey
conformtothemanufacturer’sspecifications.

15. PERFORMANCE QUALIFICATION (PQ)
•Establishingconfidencethroughappropriatetestingthatthe
finishedproductorprocessproducedbyaspecifiedprocessmeets
allreleaserequirementsforfunctionalityandsafetyandthat
proceduresareeffectiveandreproducible.
•Inpractice,theperformancequalificationistheexecutedtest
protocoldocumenting thatasystemmeetsthedefined
requirementstofunctionintheproductionenvironment.