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biologicalproducts.IfanNRAsodesires,theseWHOGuidelinesmaybe adoptedasdefinitivenationalrequirements,ormodificationsmaybe justifiedandmadebytheNRA. WHO发表的指南力求在本质上具有科学性和指导性。以下章节将为各国监管 当局及生物制品生产厂家提供指导。各国监管当局可根据需要,完全采用WHO的 ...
WHO Medicines website (/teams/health-product-and-policy-standards/standards-and- specifications/pharmaceuticals/current-projects) for comments under the “Working documents in public consultation” link. If you wish to receive all our draft guidelines, please send your email address to joness i@ ...
In view of an old publication date,and the recent need for new guidelines arising from inspections carried out forCOVID-19 therapeutics, the World Health Organization (WHO) PrequalificationTeam-Inspection Services (PQT INS) raisedthe urgency for a revision of the WHO G... 文档格式:PDF | ...
附录2 WHO药品GMP指南_中英文_.pdf,Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 附录2 WHO药品GMP:主要原则 Introduction引言 General considerations总则 Glossary术语 Quality management in the medicines industry: philo
内容提示: Working document QAS/20.842 May 2020 DRAFT WORKING DOCUMENT FOR COMMENTS : Good manufacturing practices: water for pharmaceutical use Please send your comments to Dr Sabine Kopp, Team Lead, Norms and Standards for Pharmaceuticals, Technical Standards and Specifications (kopps@who.int), with...
recentneedfornewguidelinesarisingfrominspections carriedoutforCOVID-19therapeutics,theWorldHealth Organization(WHO)PrequalificationTeam-Inspection Services(PQTINS)raisedtheurgencyforarevisionof theWHOGoodmanufacturingpractices forinvestigationalpharmaceuticalproductsfor ...
上次检查日期Typeofinspection.检查方式Scopeofinspection.检查范围Theregulatoryauthority.行政机关GMPguidelinesusedforassessingcompliance.用于评估符合性的GMP指南Forforeigninspectionsstatewhether,thenationalregulatoryauthority(NRA)ofthecountrywheretheinspectiontookplacewasinformedandwhetherittookpartintheinspection.否参与检查。
(Notalloftheaspectsofthisannexmaynecessarilyapplytoproductsincategorya).NoteIndrawingupthisguidance,dueconsiderationhasbeen:..,andattentionisthereforedirectedtootherguidelinesissuedbytheCommitteeforProprietaryMedicinalProducts(CPMP),foruidanceonmonoclonalantibodiesandbinantDNAtechnology(“Therulesgoverningmedicinalproduct...
_中英文_附录2 WHO药品GMP指南