Sarfaraz K. Niazi - Handbook of Pharmaceutical Manufacturing Formulations, Second Edition, Volume 6_ Sterile Products (2009).pdf

Sarfaraz K. Niazi - Handbook of Pharmaceutical Manufacturing Formulations, Second Edition, Volume 6_ Sterile Products (2009).pdf

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SarfarazK.NiaziPharmaceuticalScientist,Inc.Deerfield,Illinois,USAVOLUMESIXSecondEditionHandbookofPharmaceuticalManufacturingFormulationsSterileProductsNiazi_978-1420081305_TP.indd25/27/094:

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978-1-4200-8130-5（Volume6;Hardcover）Thisbookcontainsinformationobtainedfromauthenticandhighlyregardedsources.Reprintedma-terialisquotedwithpermission,andsourcesareindicated.Awidevarietyofreferencesarelisted.Reasonableeffortshavebeenmadetopublishreliabledataandinformation,buttheauthorandthepublishercannotassumeresponsibilityforthevalidityofallmaterialsorfortheconsequenceoftheiruse.Nopartofthisbookmaybereprinted,reproduced,transmitted,orutilizedinanyformbyanyelectronic,mechanical,orothermeans,nowknownorhereafterinvented,includingphotocopying,microfilming,andrecording,orinanyinformationstorageorretrievalsystem,withoutwrittenpermissionfromthepublishers.Forpermissiontophotocopyorusematerialelectronicallyfromthiswork,please（http:

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Productorcorporatenamesmaybetrademarksorregisteredtrademarks,andareusedonlyforidentificationandexplanationwithoutintenttoinfringe.LibraryofCongressCataloging-in-PublicationDataNiazi,Sarfaraz,1949-Handbookofpharmaceuticalmanufacturingformulations/SarfarazK.Niazi.2nded.p.;cm.Includesbibliographicalreferencesandindex.ISBN-13:

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1-4200-8116-0（v.1）（hardcover:

alk.paper）etc.1.DrugsDosageformsHandbooks,manuals,etc.I.Title.DNLM:

1.DrugCompoundingHandbooks.2.DosageFormsHandbooks.3.FormulariesasTopicHandbooks.4.Technology,PharmaceuticalHandbooks.QV735N577h2009RS200.N532009615?

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58CharCount=PrefacetotheSeriesSecondEditionThescienceandtheartofpharmaceuticalformulationkeepsevolvingasnewmaterials,methods,andmachinesbecomereadilyavailabletoproducemorereliable,stable,andrelease-controlledformulations.Atthesametime,globalizationofsourcingofrawandfinishedpharmaceuticalsbringschal-lengestoregulatoryauthoritiesandresultsinmorefrequentrevisionstothecurrentgoodmanufacturingpractices,regu-latoryapprovaldossierrequirements,andthegrowingneedforcostoptimization.Sincethepublicationofthefirsteditionofthisbook,alothaschangedinalloftheseareasofimpor-tancetopharmaceuticalmanufacturers.Thesecondeditionbuildsonthedynamicnatureofthescienceandartoffor-mulationsandprovidesanevermoreusefulhandbookthatshouldbehighlywelcomedbytheindustry,theregulatoryauthorities,aswellastheteachinginstitutions.Thefirsteditionofthisbookwasagreatsuccessasitbroughtunderoneumbrellathemyriadofchoicesavailabletoformulators.Thereaderswereveryresponsiveandcom-municatedwithmefrequentlypointingouttotheweaknessesaswellasthestrengthsofthebook.Thesecondeditiontotallyrevisedattemptstoachievethesebymakingmajorchangestothetext,someofwhichinclude:

1.Complete,revisederrorscorrectedandsubjectmatterreorganizedforeasyreference.WhereasthisserieshassixvolumesdifferentiatedonthebasisofthetypeofdosageformandaseparateinclusionoftheU.S.OTCproducts,ideallytheentirecollectionisneededtoben-efitfromthemyriadoftopicsrelatingtoformulations,regulatorycompliance,anddossierpreparation.2.Totalnumberofpagesisincreasedfrom1684to2726.3.Totalnumberofformulationsisexpandedbyabout30%withmanynewlyapprovedformulations.4.Novelformulationsarenowprovidedforavarietyofdrugs;thesedataarecollectedfromthemassiveintellec-tualpropertydataandsuggesttowardthefuturetrendofformulations.WhilesomeoftheseformulationsmaynothavebeenapprovedintheUnitedStatesorEurope,thesedoprovideadditionalchoices,particularlyfortheNDApreparation.Asalways,itistheresponsibilityofthemanufacturertoassurethattheintellectualpropertyrightsarenotviolated.5.Asignificantchangeinthiseditionistheinclusionofcommercialproducts;whilemostofthisinformationisculledoutfromtheopensourcesuchastheFOIA（http:

/www.fda.gov/foi/default.htm）,Ihavemadeat-temptstoreconstructthecriticalportionsofitbasedonwhatIcallthegenerallyacceptablestandards.Thedrugcompaniesareadvisedtoassurethatanyintellec-tualpropertyrightsarenotviolatedandthisappliestoallinformationcontainedinthisbook.Thefreedomofinformationact（FOIA）isanextremelyusefulconduitforreliableinformationandmanufacturersarestronglyurgedtomakeuseofthisinformation.Whereasthisin-formationisprovidedfreeofcharge,theprocessofob-tainingtheinformationmaybecumbersome,inwhichcase,commercialsourcesofthesedatabasescanproveuseful,particularlyforthenon-U.S.companies.6.AlsoincludedarethenewGoodManufacturingGuide-lines（2007）withamendments（2008）fortheUnitedStatesandsimilarupdatesforEuropeanUnionandWHO;itisstronglyurgedthatthecompaniesdiscontinueusingallolddocumentsastherearesignificantchangesinthere-visedform,manyofthemarelikelytoreducethecostofGMPcompliance.7.Detailsondesignofcleanroomsisanewentrythatwillbeofgreatusetosterileproductmanufacturers;whereasthedesignandflowofpersonnelandmaterialflowisofcriticalnature,regulatoryagenciesviewthesedifferentlyandthemanufacturerisadvisedalwaystocomplywithmoststringentrequirements.8.Additionofaself-auditingtemplateineachvolumeoftheseries.WhilethecGMPcomplianceisacomplexis-sueandtherequirementsdiversifiedacrosstheglobe,thebasiccomplianceremainsuniversal.IhavechosentheEuropeanUnionguidelines（asthesearemoreintunewiththeICH）toprepareaself-auditmodulethatIrec-ommendthateverymanufactureradoptasaroutinetoassureGMPcompliance.InmostinstancesreadingthetemplatebythoseresponsibleforcompliancewithkeepthemsensitivetotheneedsofGMP.9.OTCproductscross-referencedinothervolumeswhereappropriate.Thiswasnecessarysincetheregulatoryau-thoritiesworldwidedefinethisclassofdrugdifferently.Itisimportanttoiteratethatregardlessoftheprescrip-tionortheOTCstatusofaproduct,therequirementsforcompliancewiththecGMPapplyequally.10.OTCmonographstatusisanewsectionaddedtotheOTCvolumeandthisshouldallowmanufacturerstochoseap-propriateformulationsthatmaynotrequireafilingwiththeregulatoryagencies;itisimportanttoiteratethatanapprovedOTCmonographincludesdetailsofformula-tionincludingthetypesandquantitiesofactivedrugandexcipients,labeling,andpresentation.Toqualifytheex-emption,themanufacturermustcomplywiththemono-graphinitsentirety.However,subtlemodificationsthataremerelycosmeticinnatureandwherethereisanevi-dencethatthemodificationwillnotaffectthesafetyandefficacyoftheproductscanbemadebutrequirepriorapprovaloftheregulatoryagenciesandgenerallytheseapprovalsaregranted.11.Expandeddiscussiononcriticalfactorsinthemanufac-turingofformulationsprovided;frombasicshortcutstosmartmodificationsnowextendtoalldosageforms.Pharmaceuticalcompoundingisoneoftheoldestpro-fessionsandwhereastheartofformulationshasbeenvSPHSPHIHBK039-fmIHBK039-Niazi-FMMay26,200919:

58CharCount=viPrefacetotheSeriesSecondEditionrelegatedtomoreobjectiveparameters,theart