EDQM 使用CEP描述起始物料来申请另一个CEP 2016.9 英文.pdfVIP

Certification of Substances Division FML/CB PUBLIC DOCUMENT (LEVEL 1) (LEVEL 1) English only/Anglais seulement PA/PH/CEP (14) 06, 1 R Strasbourg, September 2016 Certification of suitability to Monographs of the European Pharmacopoeia Use of a CEP to describe a material used in an application for another CEP 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 (14) 06 1R Certification of Substances Division 1. Introduction A material which is the subject of a CEP (hereafter CEP X) may be used in the synthesis of a substance for which a separate CEP is requested (hereafter CEP Y) and may be an intermediate or a starting material in the process described for CEP Y. ICH Q11 includes information on the selection of starting materials and should provide the basis for the decision and justification of whether the material covered by CEP X is a starting material or an intermediate. This document describes the practical aspects of a CEP submission where another CEP is referenced. The use of CEP X in CEP Y is based on the fact that the manufacturing process and controls described in the application for CEP X have been assessed before CEP X was granted. The applicant should make clear in the application whether the substance covered by the referenced CEP X is actually an intermediate in the manufacture of the substance covered by the new CEP Y or i