生物制品清洁验证考虑要点(中英文版)(PDA TR49 节选1).pdfVIP

生物制品清洁验证考虑要点（中英文版）(PDATR49节选1)

1.0Introduction介绍

Cleaningvalidationplaysanimportantroleinreducingthepossibilityofproduct

contaminationfrombiopharmaceuticalmanufacturingequipment.It

demonstratesthatthecleaningprocessadequatelyandconsistentlyremoves

productresidues,processresiduesandenvironmentalcontaminantsfromthe

cleanedequipment/system,sothatthisequipment/systemcanbe

safelyusedforthemanufactureofdefinedsubsequentproducts(whichmay

bethesameoradifferentproduct).AsusedinthisTechnicalReport,“product”

maybeadrugproduct,bulkactive,intermediate,oranothertypeofformulati

on.If“drugproduct”isintended,thatterminologywillbeutilized.While

cleaningvalidationforbiotechnologymanufacturinghasmanyofthesame

elementsasforotherpharmaceuticalmanufacturing,thereareenough

differencessuchthataseparateTechnicalReportfocusingonbiotechnology

cleaningvalidationisappropriate.

清洁验证在生物制药生产设备降低产品污染方面扮演了一个重要的角色。清

洁验证证明清洁工艺能够充分的并始终如一的从清洗的设备/系统上去除

产品残留、工艺残留和环境污染，以保证该设备/系统可以安全的应用到

后来产品（可能是同一种产品或是不同的产品）的生产中。在本技术报告中，

“产品”可以是药品，活性原料，中间体，或其他类型的构成。如果“制药产

品”是预期的，该术语也将会用到。生物技术生产的清洁验证有很多和其他产

品生产相同的因素，但在单独的技术报告中仍然有很多的不同之处，本报告

关注于生物技术清洁验证。

PreviousPDAdocumentsoncleaningvalidation,includingthe1998PDA

TechnicalReportNo.29,PointstoConsiderforCleaningValidationandthe1996

monographCleaningandCleaningValidation:ABiotechnologyPerspective

providevaluableinsightsforbiotechnologymanufacturers.(1,2)However,this

reportpresentsmoreupdatedinformationthatisalignedwithlifecycle

approachestovalidationandtheInternationalConferenceonHarmonisation(ICH)

guidelinesQ8(R2),PharmaceuticalDevelopment,Q9,QualityRisk

Management,andICHQ10,PharmaceuticalQ