WHOTRS第55次报告Annex3Goodmanufacturingpractices:waterforpharmaceuticaluse优良生产规范（GMP）：制药用水

Background背景

Unlikeotherproductorprocessingredients,waterisusuallydrawnfromanondemandsystemandisnotsubjecttotestingandbatchorlotreleasepriortouse.Thusitisessentialthatwaterquality(includingmicrobiologicalandchemicalquality)throughoutproduction,storageanddistributionprocessesiscontrolled.

与其他产品或工艺成分不同，水通常是从按需制备的系统提取，且在使用前不受检测和批放行限制。因此，对从生产、储存和分配全过程中的水质(包括微生物和化学质量)进行控制是至关重要的。

Inrecentyears,followingextensiveconsultationswithstakeholders,severalpharmacopoeiashaveadoptedrevisedmonographsonwaterforinjection(WFI)thatallowforproductionbynon-distillationtechnologies.In,theWorldHealthOrganization(WHO)ExpertCommitteeonSpecificationsforPharmaceuticalPreparations(ECSPP)re

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