WHO草案-202005-使用共用设施生产时清洁验证中为识别污染风险而建立残留限度的不同方.pdf

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WorkingdocumentQAS/20.849Pointstoconsideronthedifferentapproaches–includingHBEL–toestablishcarryoverlimitsincleaning

validationforidentificationofcontaminationriskswhenmanufacturinginsharedfacilities202005

DRAFTWORKINGDOCUMENTFORCOMMENTS:

Pointstoconsideronthedifferentapproaches–

includingHBEL–toestablishcarryoverlimitsin

cleaningvalidationforidentificationof

contaminationriskswhenmanufacturinginshared

facilities

使用共用设施生产时清洁验证中为识别污染风险而

建立残留限度的不同方法—包括HBEL—考量要点

PleasesendyourcommentstoDrValeriaGigante,TechnicalOfficer,NormsandStandardsforPharmaceuticals,

TechnicalStandardsandSpecifications(gigantev@),withacopytoMsClaireVogel(vogelc@)

before30June2020.PleaseuseourattachedCommentsTableforthispurpose.

OurworkingdocumentsaresentoutelectronicallyandtheywillalsobeplacedontheWHOMedicineswebsite

(/medicines/areas/quality_safety/quality_assurance/guidelines/en/)forcommentsunderthe“Current

projects”link.Ifyouwishtoreceiveallourdraftguidelines,pleasesendyouremailaddresstojonessi@andyour

namewillbeaddedtoourelectronicmailinglist.

©WorldHealthOrganization2020

Allrightsreserved.

Thisdraftisintendedforarestrictedaudienceonly,i.e.theindividualsandorganizationshavingreceivedthisdraft.Thedraftmaynotbe

reviewed,abstracted,quoted,reproduced,transmitted,distributed,translatedoradapted,inpartorinwhole,inanyformorbyanymeans

outsidetheseindividualsandorganizations(includingtheorganizationsconcernedstaffandmemberorganizations)withoutthepermission

oftheWorldHealthOrganization.Thedraft

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