WHO：清洁验证新指南（中英文对照版）！.pdfVIP

WHO：：清清洁洁验验证证新新指指南南（（中中英英⽂⽂对对照照版版））！！

PointstoconsiderwhenincludingHealth-BasedExposureLimits(HBELs)incleaningvalidation

清清洁洁验验证证使使⽤⽤基基于于健健康康的的暴暴露露限限（（HBEL））的的考考量量

1.Introductionandbackground

介绍背景

2.Scope

范围

3.Glossary

术语

4.Historicalapproach

传统⽅法

5.Newapproaches

新的⽅法

5.1ocumentation

⽂件

5.2Equipment

设备

5.3Cleaningagents

清洁剂

5.4Sampling

取样

5.5Cleanabilitystudies

清洁能⼒研究

5.6Riskmanagement

风险评估

5.7GuidanceforHealth-BasedExposureLimits(HBELs)setting

基于健康的暴露限设定的指南

5.8Acceptancecriteria

接受标准

5.9Analyticalprocedures

分析⽅法

5.10ataintegrity

数据完整性

5.11Cleaningvalidationandcleaningverification

清洁验证清洁确认

5.12Visuallyclean

⽬视⼲净

5.13Cleaningprocesscapability

清洁⼯艺能⼒

5.14Personnel

⼈员

5.15Qualitymetricsandperformanceindicators

质量量度性能指标

质量量度性能指标

5.16Lifecycle

⽣命周期

References

参考⽂献

Furtherreading

扩展阅读

Annex1

附录1

1Introductionandbackground

介介绍绍及及背背景景

TheWorldHealthOrganization(WHO)haspublishedtheguidelineentitledGoodmanufacturingpracticesforpharmaceuticalproducts:mainprinciplesin

theWHOTechnicalReportSeries,No.986,Annex2,2014(1).

WHO于2014年TRS986附录2发布了题为“药品GMP：主则”的指南。

TheWHOSupplementaryguidelinesongoodmanufacturingpractice:validationwerepublishedin2006andweresupportedbysevenappendices.The

maintext(2)anditsappendixes(3,4,6,7,8,9)wererevisedbetween2006and2019.Appendix3,relatingtocleaningvalidation(5),wasnotupdatedat

thattime.Itsrevision,however,wasdiscussedduringaninformalconsultationheldinGeneva,Switzerland,inJuly2019.Theoutcomeofthediscussion

waspresentedtotheWHOExpertCommitteeonSpecificationsforPharmaceuticalProducts(ECSPP)meetinginOctober2019.The

ECSPPacknowledgedtheimportanceofharmonizationinregulatoryexpectationswithregardstocleaningvalidationapproaches.TheExpertCommittee

recommendeda“Pointstoconsider”