How QbD and the FDA Process Validation Guidance Affect Product Development and Operations， Part 2 Peter H. Calcott.pdf

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1、FOCUSON...COMPLIANCEHowQbDandtheFDAProcessValidationGuidanceAffectProductDevelopmentandOperations,Part2byPeterH.Calcottarlierthisyear,theFDAissueditslong-awaitedprocessEvalidationguidancedocument,whichhadbeenseveralyearsindevelopment.Itiswellwrittenandeffectivelyarticulateswhatmany

2、progressivecompanieshavebeenthinkinganddoingforyears.Butmanypeopleintheindustryareaskingquestions.Part1ofthisarticledescribedthehistoryofprocessvalidationbeforetheFDA’squalitybydesign(QbD)initiativeanddiscussedQbDingeneral.Italsodescribedthenewprocessvalidationparadigmaccordingtoth

3、e2011guidanceinaQbDcontext.Part2concludesherewithIoanaDavIes(www.Istockphoto.com)examples,afocusonpostapprovalactivities,andgeneralimplications.whatisperformedandwhy.DecidingyoucanmovetothenextcomponenttoperformanactivityatadiscreteofyourPVprocess.TwoExamplEspointinaprocessmustbede

4、scribedTherearetwotypesofrawACellCultureUnitOperation:Afterwithinclusionofitsrationaleandmaterialsareusedinproduction.expansionoffrozencellsfromvialsinconstraintswithineachaction.InthisClassicalrawmaterialsincludevesselsofincreasingsize,youhaveparticularphase,activelygrowingcellsco

5、mponentsofcellcultureorsufficientbiomasstoexpressaproteinmustbetransferredanddilutedintofermentationbroth(amixtureofinyourproductionreactor(productionfreshmediumwhilepreventingbothinorganicandorganicmaterialsthatphase).Thisstepinthemanufacturingphysicalandchemicalshock.Theformtheba

6、salmedium),andprocesswillexpressabatchofproteindilutedcellsgrowforaperiod(withadditionalnutrients(e.g.,acarbonthatwillbesubsequentlyrecoveredappropriateadditions)toyieldansource,acid-bufferingmaterialtoandpurifiedtoyieldtheBDS.ItisactivebiomassthatcanbeconvertedmaintainpH,andinduce

7、rs).Theimportanttoclearlydefinethepurposetoproductionmodesothatitsenergyqualityofsuchmaterialsisdefinedofthisstepandtheneedsforeachcantranslatefrombiomassproductioninofficialspecificationsusedtoelementoftheprocess,whichcometoproductexpression.Theculturepurchasethem,whichshouldbedir

8、ectlyfromdevelopmentwork.F