EuropeanMedicinesAgency7WestferryCircus,CanaryWharf,London,E144HB,UKTel.(44-20)74188400Fax(44-20)74188613E-mail:mail@emea.europa.euhttp://.emea.europa.eu©EuropeanMedicinesAgency,2008.Reproductionisauthorisedprovidedthesourceisacknowledged.London,21February2008Doc.Ref.EMEA/CHMP/SWP/4446/2000COMMITTEEFOR...
Ref. EMEA/CHMP/SWP/4446/2000 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE SPECIFICATION LIMITS FOR RESIDUES OF METAL CATALYSTS OR METAL REAGENTS DRAFT AGREED BY THE SAFETY WORKING PARTY 欧洲药品评价局EMEA和欧洲药品质量管理局(EDQM)介绍 欧洲药品评价局 EMEA 和欧洲药品质量...
Impurities LimitsofgenotoxicimpuritiesCPMP/SWP/5199/02EMEA/CHMP/QWP/251344/2006CPMP/QWP/1529/04CPMP/ICH/2738/99-ICHQ3B(R2)CPMP/ICH/2737/99-ICHQ3A(R2)CPMP/ICH/283/95-ICHQ3C(R3)CPMP/QWP/450/03Jun2006Jan2007 Q&Ashere ControlofImpuritiesofPharmacopoeialSubstancesImpuritiesinNewMedicinalProducts(ICHQ3...