Glossary of equivalent terms used in the Certificate template (nonexhaustive) active substances = active pharmaceutical ingredients/constituents batch = lot dosage form = pharmaceutical form manufacturer = fabricator manufacturing/manufacture = fabrication manufacturing authorisation = establishment licence medicinal product = pharmaceutical product = drug product quality control = testing
Glossary of equivalent terms used in the Certificate template (nonexhaustive)
Glossary EU Revision History Adopted and published final version 1 February 2001 Revision 1 - only explanatory note 26 April 2002 Revision 2 - only explanatory note 22 October 2002 Revision 3 - only explanatory note 16 December 2002 Revision 4 - Draft 3 EU agreed, awaiting MRA partners comments 27 January 2004
Glossary Revision 4 additions to include investigational medicinal products 1 May 2004
Glossary Revision 5 editorial changes, extension of use of the certificate to other arrangements on GMP and addition of quality control sites was agreed; draft subject to comments of MRA/ACAA partners; 15 September 2010 addition of a glossary and adoption by GMDP IWG 24 May 2011