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The Environmental Monitoring Program In a GMP …

I,MICROBIOLOGYTPICSTheEnvironmentalMonit oringProgramInaGMPE nvironmentScottSutton"MicrobiologyTopics " Theroutineenvironmentalmonitoringprogram isacriticalaspectofdocumentingthestateof controlofthefacility <1116>"MicrobiologicalControlandMonitoringEnvi ron-mentsUsedfortheManufactureofHealthca reProducts"isprovided Explicitexamplesareprovidedfrompublicall y-availablesources(FDA-483observationsan dwarningletters)ofenforcementactivi-ties basedongoodmanufacturingpracticefailures intheenviron-mentalmonitoringprogram ~-~~-~-~-~~---~--=~-~~-----~e~~~__-'-~'- ~~--r""~--~~~~_IiScottSutton,CoordinahHI NTRODUCTIONT hequalification,orrequalification, especiallytrue: Cleaningstudies Contaminationcontrolplanning(1) Equipmentholdtimestudies(establishmentof cleananddirtyholdtimes~processholdtimesa reprocess-speCific) Selectionofsamplesitesforenvironmentalmo nitoring (EM) Program ,itssamplesites,frequencyofte sting, methodtoqualifyandjustifytheselectionof thesamplesiteswithina facilityusedforroutineenvironmentalmonit oringis ,thisdiscussiondoesnotincludesamplingoft hewatersystem,gasses, complexprogramsuchasenvironmentalmoni-to ring, , (2)is :"Inasepticprocessing, oneofthemostimportantlaboratorycontrolsi s ( ,whena givenbatchis beingmanufactured) ,allowingforimplementationofcorrec-tions beforeproductcontaminationoccurs( ).

cal industry. Even the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co­ operation Scheme (PIC/S), which generally can be counted on to provide details on almost everything microbiological, is silent on this point (12). Oddly enough, even the Parenteral DrugAssociation (PDA)'s Technical Report #13 (13) offers no help here.

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