Transcription of Stability Existing Corrected March 2007
{{id}} {{{paragraph}}}
Example: bankruptcy
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.
they are named under the headings “purity test” and / or “section on impurities”. b) For active substances not described in an official pharmacopoeial monograph, there are two options: -When available, it is acceptable to provide the relevant data published in the literature to support the proposed degradation pathways;
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: