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 ...
As shown above the assessment is done by EDQM, mainly to facilitate EU MA filings, but also other non-EU countries accept and facilitate the CEP. Although sometimes wrongly mentioned by CEP holders, the grant of a CEP by EDQM says nothing about the GMP conditions of the API manufacturing. ...
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 ...