EDQM 在认证程序中执行ICH Q3D 2016.8 英文.pdfVIP

Certification of Substances Division LS/CB PUBLIC DOCUMENT LEVEL 1) LEVEL 1) PA/PH/CEP (16) 23 Strasbourg, August 2016 Certification of suitability to the Monographs of the European Pharmacopoeia Implementation of ICH Q3D in the Certification Procedure Addresses Role Date TAB For adoption July 2016 TAB Adopted by correspondence August 2016 Address: 7 Allée Kastner, CS 30026 F-67081 Strasbourg (France) Tel: +33 (0) 3 88 41 30 30 – Fax: +33 (0) 3 88 41 27 71 - e-mail: cep@edqm.eu Internet: http://www.edqm.eu EDQM PA/PH/CEP 16) 23 Certification of Substances Division 1. Background The ICH Q3D guideline on elemental impurities is effective in the European Union from June 2016 for new marketing authorisation applications and from December 2017 for authorised medicinal products. This document is intended to serve as guidance on how to implement ICH Q3D in the procedure for “Certification of Suitability to the monographs of the European Pharmacopoeia” (CEP). ICH Q3D covers 24 elements (classified under the following classes 1, 2A, 2B and 3) and gives permitted daily exposure (PDE) in drug products. ICH Q3D is not limited to reagents and catalysts in drug substance or excipients, but also considers all contributions from manufacture including manufacturing equipment, water and container-closure system. The ICH Q3D guidel