GMP • A GMP Certificate should be issued by the participating Inspectorate (EMA/INS/GMP/459921/2010 Rev 13 Compilation of Community Procedures) Dr Florence Benoit-Guyod © 2012 EDQM, Council of Europe, All rights reserved 25 Negative Outcome • In case of critical/major GMP deficiencies ...
A certificate of suitability to the monographs of the European Pharmacopoeia (CEP) issued by the EDQM is considered to replace the relevant sections in the application for marketing authorization demonstrating the quality of substances for pharmaceutical use. The inclusion of a CEP in an MAA ...
with the GMP • A GMP Certificate may be issued by the participating Inspectorate (EMEA/INS/GMP/871/04) Dr Florence Benoit-Guyod, March 2010 ©2010 EDQM, Council of Europe, All rights reserved 16 Negative Outcome • In case of critical/major GMP deficiencies or in case of ...
GMP • A GMP Certificate should be issued by the participating Inspectorate (EMA/INS/GMP/459921/2010 Rev 13 Compilation of Community Procedures) Dr Florence Benoit-Guyod © 2012 EDQM, Council of Europe, All rights reserved 25 Negative Outcome • In case of critical/major GMP deficiencies ...