Analytical method validation and instrument performance verification

316 Pages·2004·3.3 MB·English

by  Chung Chow Chan

ANALYTICAL METHOD VALIDATION
AND INSTRUMENT PERFORMANCE
VERIFICATION
Edited by
CHUNG CHOW CHAN
Eli Lilly Canada, Inc.
HERMAN LAM
GlaxoSmithKline Canada, Inc.
Y. C. LEE
Patheon YM, Inc.
XUE-MING ZHANG
Novex Pharma
A JOHN WILEY & SONS, INC., PUBLICATION
ANALYTICAL METHOD VALIDATION
AND INSTRUMENT PERFORMANCE
VERIFICATION

ANALYTICAL METHOD VALIDATION
AND INSTRUMENT PERFORMANCE
VERIFICATION
Edited by
CHUNG CHOW CHAN
Eli Lilly Canada, Inc.
HERMAN LAM
GlaxoSmithKline Canada, Inc.
Y. C. LEE
Patheon YM, Inc.
XUE-MING ZHANG
Novex Pharma
A JOHN WILEY & SONS, INC., PUBLICATION
Copyright2004byJohnWiley&Sons,Inc.Allrightsreserved.
PublishedbyJohnWiley&Sons,Inc.,Hoboken,NewJersey.
PublishedsimultaneouslyinCanada.
Nopartofthispublicationmaybereproduced,storedinaretrievalsystem,ortransmittedinany
formorbyanymeans,electronic,mechanical,photocopying,recording,scanning,orotherwise,
exceptaspermittedunderSection107or108ofthe1976UnitedStatesCopyrightAct,without
eitherthepriorwrittenpermissionofthePublisher,orauthorizationthroughpaymentofthe
appropriateper-copyfeetotheCopyrightClearanceCenter,Inc.,222RosewoodDrive,Danvers,
MA01923,978-750-8400,fax[phone],oronthewebatwww.copyright.com .Requeststo
thePublisherforpermissionshouldbeaddressedtothePermissionsDepartment,JohnWiley&
Sons,Inc.,111RiverStreet,Hoboken,NJ07030,[phone],fax[phone].
LimitofLiability/DisclaimerofWarranty:Whilethepublisherandauthorhaveusedtheirbest
effortsinpreparingthisbook,theymakenorepresentationsorwarrantieswithrespecttothe
accuracyorcompletenessofthecontentsofthisbookandspecificallydisclaimanyimplied
warrantiesofmerchantabilityorfitnessforaparticularpurpose.Nowarrantymaybecreatedor
extendedbysalesrepresentativesorwrittensalesmaterials.Theadviceandstrategiescontained
hereinmaynotbesuitableforyoursituation.Youshouldconsultwithaprofessionalwhere
appropriate.Neitherthepublishernorauthorshallbeliableforanylossofprofitoranyother
commercialdamages,includingbutnotlimitedtospecial,incidental,consequential,orother
damages.
ForgeneralinformationonourotherproductsandservicespleasecontactourCustomerCare
DepartmentwithintheU.S.at877-762-2974,outsidetheU.S.at317-572-3993or
fax[phone].
Wileyalsopublishesitsbooksinavarietyofelectronicformats.Somecontentthatappearsin
print,however,maynotbeavailableinelectronicformat.
LibraryofCongressCataloging-in-PublicationData:
Analyticalmethodvalidationandinstrumentperformanceverification/
ChungChowChan...[etal.].
p. ;cm.
Includesbibliographicalreferencesandindex.
ISBN0-471-25953-5(cloth:alk.paper)
1. Drugs—Analysis—Methodology—Evaluation. 2.
Laboratories—Equipmentandsupplies—Evaluation.3.
Laboratories—Instruments—Evaluation.
[DNLM:1.Chemistry,Pharmaceutical—instrumentation.2. Chemistry,
Pharmaceutical—methods.3. ClinicalLaboratoryTechniques—standards.
4. Technology,Pharmaceutical—methods.QV744A5322004]I.Chan,
ChungChow.
RS189.A5682004
610(cid:1).28—dc21
2003014141
PrintedintheUnitedStatesofAmerica.
10987654321
CONTENTS
Contributors vii
Preface ix
1 Overview of Pharmaceutical Product Development and Its
Associated Quality System 1
ChungChowChanandEricJensen
2 Potency Method Validation 11
ChungChowChan
3 Method Validation for HPLC Analysis of Related Substances
in Pharmaceutical Drug Products 27
Y.C.Lee
4 Dissolution Method Validation 51
ChungChowChan,NeilPearson,AnnaRebelo-Cameirao,andY.C.Lee
5 Development and Validation of Automated Methods 67
ChantalIncledonandHermanLam
6 Analysis of Pharmaceutical Inactive Ingredients 85
Xue-MingZhang
7 Validation Study of JP Heavy Metal Limit Test 95
YoshikiNishiyama
v
vi CONTENTS
8 Bioanalytical Method Validation 105
FabioGarofolo
9 Procurement, Qualification, and Calibration of Laboratory
Instruments: An Overview 139
HermanLam
10 Performance Verification of UV–Vis Spectrophotometers 153
HermanLam
11 Performance Verification of HPLC 173
HermanLam
12 Operational Qualification of a Capillary Electrophoresis
Instrument 187
NicoleE.Baryla
13 LC-MS Instrument Calibration 197
FabioGarofolo
14 Karl Fisher Apparatus and Its Performance Verification 221
RickJairam,RobertMetcalfe,andYu-HongTse
15 The pH Meter and Its Performance Verification 229
Yu-HongTse,RickJairam,andRobertMetcalfe
16 Qualification of Environmental Chambers 243
GilmanWongandHermanLam
17 Equipment Qualification and Computer System Validation 255
LudwigHuber
18 Validation of Excel Spreadsheet 277
HeikoBrunner
Index 299
CONTRIBUTORS
NicoleE. Baryla, Ph.D.,EliLillyCanada,Inc.,3650DanforthAvenue,Toronto,
Ontario M1N 2E8, Canada
Heiko Brunner, Ph.D., Lilly Forschung GmbH, Essener Strasse 93, D-22419
Hamburg, Germany
Chung Chow Chan, Ph.D., Eli Lilly Canada, Inc., 3650 Danforth Avenue,
Toronto, Ontario M1N 2E8, Canada
Fabio Garofolo, Ph.D., Vicuron Pharmaceuticals, Inc., via R. Lepetit 34,
I-21040 Gerenzano, Italy
LudwigHuber, Ph.D.,Agilent Technologies, Hewlett-PackardStrasse 8, 76337
Waldbronn, Germany
ChantalIncledon, GlaxoSmithKlineCanada,Inc.,7333MississaugaRoad North,
Mississauga, Ontario L5N 6L4, Canada
Rick Jairam, GlaxoSmithKline Canada, Inc., 7333 Mississauga Road North,
Mississauga, Ontario L5N 6L4, Canada
Eric Jensen, Ph.D., Eli Lilly & Company, Indianapolis, IN
Herman Lam, Ph.D., GlaxoSmithKline Canada, Inc., 7333 Mississauga
Road North, Mississauga, Ontario L5N 6L4, Canada
Y.C. Lee, Ph.D., Patheon YM, Inc., 865 York Mills Road, Toronto, Ontario
M3B 1Y5, Canada
Robert Metcalfe, Ph.D., GlaxoSmithKline Canada, Inc., 7333 Mississauga
Road North, Mississauga, Ontario L5N 6L4, Canada
vii