(CEP database and Certification webpages) • Holder and manufacturer are informed and a possibility of hearing is given • Statement of GMP non-compliance should be issued by the EEA Inspectorate Dr Florence Benoit-Guyod © 2012 EDQM, Council of Europe, All rights reserved 27 Suspension ...
9-2 EDQM对欧盟GMP的要求和原料药厂商检查-2 英文 q p EU GMP requirements and inspections of API manufacturers organized by EDQM 2012 June 2012 Shanghai Shanghai, , 29 29 June
granting the CEP • Draw attention to a specific point; e.g. tray lyophilisation Suspicion regarding the dossier • Inconsistencies in the data • Suspicion of fake data Potential weak points: process-related or specification-related
(CEP database and Certification webpages) • Holder and manufacturer are informed and a possibility of hearing is given • Statement of GMP non-compliance is issued by the EEA Inspectorate Dr Florence Benoit-Guyod, March 2010 ©2010 EDQM, Council of Europe, All rights reserved ...
(CEP database and Certification webpages) • Holder and manufacturer are informed and a possibility of hearing is given • Statement of GMP non-compliance should be issued by the EEA Inspectorate Dr Florence Benoit-Guyod © 2012 EDQM, Council of Europe, All rights reserved 27 Suspension ...