Validation and Qualification in Analytical Laboratories PDF
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Validation and Qualification in Analytical Laboratories HUBER_978-0849382673_TP.indd 1 6/22/07 12:59:33 PM Validation and Qualification in Analytical Laboratories Second Edition Ludwig Huber Agilent Technologies Waldbronn, Germany HUBER_978-0849382673_TP.indd 2 6/22/07 12:59:34 PM InformaHealthcareUSA,Inc. 52VanderbiltAvenue NewYork,NY10017 (cid:1)c 2007byInformaHealthcareUSA,Inc. InformaHealthcareisanInformabusiness NoclaimtooriginalU.S.Governmentworks PrintedintheUnitedStatesofAmericaonacid-freepaper 10 9 8 7 6 5 4 3 2 1 InternationalStandardBookNumber-10:0-8493-8267-X(hardcover:alk.paper) InternationalStandardBookNumber-13:978-0-8493-8267-3(hardcover:alk.paper) Thisbookcontainsinformationobtainedfromauthenticandhighlyregardedsources.Reprinted materialisquotedwithpermission,andsourcesareindicated.Awidevarietyofreferencesare listed. 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TrademarkNotice:Productorcorporatenamesmaybetrademarksorregisteredtrademarks, andareusedonlyforidentificationandexplanationwithoutintenttoinfringe. VisittheInformaWebsiteat www.informa.com andtheInformaHealthcareWebsiteat www.informahealthcare.com LibraryofCongressCataloging-in-PublicationData Huber,Ludwig,1948- Validationandqualificationinanalyticallaboratories/LudwigHuber.–2nded. p. ; cm. Includesbibliographicalreferencesandindex. ISBN-13:978-0-8493-8267-3(hardcover:alk.paper) ISBN-10:0-8493-8267-X(hardcover:alk.paper)1.Chemistry,Analytic–Qualitycontrol. 2.Chemicallaboratories–Standards. I.Title. [DNLM:1.Chemistry,Pharmaceutical–standards. 2.Chemistry,Analytical–standards. 3.DrugIndustry–standards. 4.Laboratories–standards. 5.QualityControl. QV744H877v2007] QD75.4.Q34H832007 543.068’5–dc22 2007020360 Preface Validation and qualification of analytical methods and equipment are requiredbymanyregulations,regulatoryguidancedocuments,qualitystan- dards,andcompanypolicies.Ifexecutedcorrectly,theyalsohelptoimprove the reliability, consistency, and accuracy of analytical data. This book, Validation and Qualification in Analytical Laboratories, guides analysts, laboratory managers, quality assurance managers, and validation profes- sionals through the validation and qualification processes in analytical laboratories. Thevalidationandqualificationprocedurespresentedinthisbookhelp toensurecomplianceandquality,butwithminimalextracostandadminis- trative complexity. Its purpose is to answer the key question regarding val- idation: How much validation is needed and how much is sufficient? The recommendationsarecomplementaryratherthancontradictorytoanyregu- lations,standards,orofficialguidelines.Theyarebasedmainlyoncommon senseandcanbeusedincaseswhereinformationfromofficialguidelinesand standardsisinsufficientforday-to-daywork. This book addresses both international and national regulations and qualitystandards.Itsconcept,examples,templates,andoperatingprocedures are based on my more than twenty years of multinational experience, and incorporateallaspectsofvalidationandqualificationinuseatthetopcom- panies in these fields. Input has also been taken from personal discussions with regulatory agencies, managers, and chemists at laboratories, and from corporatequalityassurancemanagers,qualitycontrolmanagers,andvendors ofequipmentandchemicals.Readersofthisbookwilllearnhowtospeedup theirvalidationandqualificationprocesses,therebyavoidingtroublesome— andcostly—reworking,andgainingconfidenceforauditsandinspections. Readers of the best-selling first edition of this title told me that they especiallylikedthepracticalcommon-senseapproachsupportedwithbulleted lists, checklists, templates, and standard operating procedures with step-by- step instructions. In this new edition, I have incorporated and further elab- oratedonthisconcept.Forexample,Ihaveaddedtemplateswithexamples iii iv ValidationandQualificationinAnalyticalLaboratories foranequipmentmasterlist,foravalidationmasterplan,andfortestingof computersystems.Suchtoolswillhelpreaderstobetterunderstandandeasily implementqualificationandvalidationprojects. Asidefromupdatingthecorecontentofthefirstedition,creatingthis revisionalsoprovidedmewiththeopportunitytoaddresstopicsthatarenew andburgeoninginthefield.Examplesincluderiskmanagementandvalidation offunctionalityasrequiredbytheFDA’s21CFRPart11.Riskmanagement hasbeenrecommendedbyregulatoryagenciesandwillhelptofocusresources onprocessesthathaveahighimpactonproductqualityanddataintegrity.If implementedproperly,thiswillimprovethequalityofhigh-impactproducts andreducecosts.Savingscomefromspendinglittleornotimeonprocesses thathavealowimpactonproductquality. In the chapter on validation of computerized systems, we have added recommendationsforvalidationoffunctionalityasrequiredbytheFDA’sreg- ulationforelectronicrecordsandsignatures,21CFRPart11.Thistakesinto accountthatmoreandmorerecordsaregenerated,maintained,andarchived oncomputersystems. Ihavealsoaddedanewchapteronmanagingout-of-specificationtest results and failure investigations. Proper handling of deviations from prod- uctspecificationswithcorrectiveandpreventiveactionplansisanincreasing concernofhealthcareagencies.Itavoidsthepossibilityofproductsentering themarketthatareunsafeduetohighamountsofharmfulimpurities.This chapterisalsoimportantduetothefactthatprobablymorethan30%ofall FDAinspectionreportsshowinadequatehandlingofout-of-specificationtest results. This book is intended to help clarify certain current issues in the area ofvalidationandqualificationinanalyticallaboratories.Readersareencour- agedtosubmittheircommentsandsuggestions,especiallyiftheirexperiences havebeendifferentindailylaboratorywork.Commentsshouldbesubmitted totheLabComplianceWebsiteatwww.labcompliance.com. LudwigHuber Contents Preface....iii 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2. Regulations,Standards,andGuidelines . . . . . . . . . . . . . . . . . . . 9 3. TerminologyandValidationOverview . . . . . . . . . . . . . . . . . . . . 25 4. Risk-BasedValidationandQualification . . . . . . . . . . . . . . . . . . 37 5. MasterandProjectPlanningforEquipmentand ComputerSystems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 6. DesignQualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 7. InstallationQualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 8. OperationalQualification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 9. PerformanceQualificationandMaintenance. . . . . . . . . . . . . . . . 93 10. SpecialConsiderationsforSoftwareandComputerSystems . . . . . 109 11. ValidationofAnalyticalMethods . . . . . . . . . . . . . . . . . . . . . . . 125 12. DataReviewandValidationandEvaluationofUncertainty. . . . . . 155 13. HandlingOut-of-SpecificationSituations . . . . . . . . . . . . . . . . . . 165 14. (Certified)ReferenceStandards. . . . . . . . . . . . . . . . . . . . . . . . . 179 15. People . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189 16. ProficiencyTestingforExternalLaboratoryQualification . . . . . . 209 17. Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215 AppendixA. Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229 AppendixB. OQTestsforSelectedEquipment . . . . . . . . . . . . . . . 243 AppendixC. Selected(Standard)OperatingProcedures . . . . . . . . . 259 AppendixD. BooksintheAreaofQualification andValidation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281 AppendixE. References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291 Index....299 v 1 Introduction The purpose of any chemical analytical measurement is to get consistent, reliable, and accurate data. There is no doubt that incorrect measurement resultscanleadtotremendouscosts,forexample: (cid:1) Ifaproductwithincorrectlymeasuredspecificationsismarketed,it mayhavetoberecalled. (cid:1) Ifdrugswithundetectedimpuritiesaredistributed,theycanhavea negativeimpactonpeoples’health. (cid:1) If harmful contaminants in environmental or food samples are not detected,theycanbedangeroustotheenvironmentortoconsumers. Inaddition,reportingincorrectanalyticalresultsatanyparticulartime leadstolossofalaboratory’sconfidenceinthevalidityoffutureresults.There- fore,anylaboratoryshoulddoitsutmosttoensuremeasuringandreporting reliableandaccuratedatawithinaknownlevelofconfidence.Validationand qualificationofprocessesandequipmentwillhelptomeetthisgoal. Thereisasecondaspecttotheimportanceofvalidationandqualifica- tion,whichisequallyimportantforthoseworkinginaregulatedoraccred- ited environment. Even though validation and qualification are frequently not directly spelled out in regulations and official guidelines, such as Good LaboratoryPractice(GLP)andGoodManufacturingPractice(GMP),orin accreditationstandards,suchastheInternationalOrganizationforStandard- ization(ISO)standard17025,theyareusuallyrequired.Thisisconfirmedby typical statements such as this one that appears in the U.S. cGMP (current GoodManufacturingPractice)regulations(1):“Equipmentshallberoutinely calibrated,inspectedandcheckedaccordingtoawrittenprogramtoensure properperformance.”Becauseoftheirdirectimpactonproductqualityand consumersafety,analyticaltestresultsinpharmaceuticalqualitycontrolare consideredhigh-riskrecordsandarefrequentlytargetsofinspectionsbythe 1
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