Stability Existing Corrected March 2007

European Medicines Agency Inspections 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 95 E-mail: @EMEA 2007 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged London, 17 December 2003 CPMP/QWP/122/02, rev 1 corr COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) GUIDELINE ON Stability TESTING: Stability TESTING OF Existing active SUBSTANCES AND RELATED FINISHED PRODUCTS DISCUSSION IN THE QUALITY WORKING PARTY (QWP) October 2003 TRANSMISSION TO THE CPMP December 2003 ADOPTION OF THE REVISION BY THE CPMP December 2003 DATE FOR COMING INTO OPERATION March 2004 Note: This guideline includes a minor correction to the earlier version CPMP/QWP/122/02 corr.

Drug Substances and Products (CPMP/ICH/2736/99 corr) and sets out the stability testing requirements for existing active substances and related finished products. For the purposes of this guideline, an existing active substance is one that has been authorised previously through a finished product within the European Community1.

Loading..

Tags:

  Active, Substance, Existing, Existing active substances, Existing active

Information

Related search queries