EDQM 现有活性物质和相关成品的稳定性测试指南 2003.12 英文.pdfVIP

European Medicines Agency Inspections 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. and CPMP/QWP/ 122/02, which came into operation in June 2003. CPMP/QWP/ 122/02 replaced CPMP/QWP/556/96. See revision history for details. 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: QW P@emea.europa.eu www.emea.europa.eu @EMEA 2007 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged Revision History Correction in March 2007: The guideline CPMP/QWP/ 122/02, rev.1, was revised in the paragraph 2.1.1 General to clarify the need for testing under accelerated or, where applicable, intermediate storage conditions. Revision in December 2003: The guideline CPMP/QWP/ 122/02, corr. was revised to be brought in