国际制药协会ISPE基本指南05卷.pdfVIP

AGUIDEFORNEWFACILITIES

VOLUME5:COMMISSIONINGANDQUALIFICATION

EXECUTIVESUMMARY

JUNE2000

ADOCUMENTDEVELOPEDINPARTNERSHIPBY:

ISPEBASELINE®GUIDE

COMMISSIONINGANDQUALIFICATIONJUNE2000

2

ISPEBASELINE®GUIDE

COMMISSIONINGANDQUALIFICATIONJUNE2000

3

ISPEBASELINE®GUIDE

COMMISSIONINGANDQUALIFICATIONJUNE2000

ISPEPHARMACEUTICALENGINEERINGGUIDE

COMMISSIONINGANDQUALIFICATION

FOREWORD

AsnotedintheBaseline®Guides,Volume1,thepharmaceuticalindustryhasexperiencedaratchetingeffectin

regulatorycompliance.Somesignificantareasofconcernarevalidation,particularlyrelatedtoautomation

systems,andthetrendtovalidatebacktosourceutilities,architecturalandHVAC.Theabsenceofaconsistent

andwidelyacceptedinterpretationofregulatoryrequirementshasledtoone-upmanship.Thispracticeofbuilding

increasinglytechnicallyadvancedfacilitieshasledtoincreasedcost,longerleadtimesand,insomecases,

delaysinbringingnewproductstomarket.

InMay1994,engineeringrepresentativesfromthepharmaceuticalindustryengagedinadiscussionwiththe

InternationalSocietyforPharmaceuticalEngineering(ISPE)andtheFoodandDrugAdministration(FDA).Thatfirst

discussionallowedforthecreationof10facilityengineeringguides,nowknownastheBaseline®Pharmaceutical

EngineeringGuides.Theseguidesareintendedtoassistpharmaceuticalmanufacturersinthedesign,construction

andcommissioningoffacilitiesthatcomplywiththerequirementsoftheFDA.Volume1,c