guideline on stability testing-emea.pdf

The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use Public 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: QWP@ @EMEA 2003 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 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 supersedes it’s earlier version CPMP/QWP/122/02 corr. and CPMP/QWP/122/02, which came into operation in June 2003. CPMP/QWP/122/02 has replaced CPMP/QWP/556/96. Public CPMP/QWP/122/02, rev 1 ?EMEA 2003 2/18 Revision History Revision in December 2003: The guideline CPMP/QWP/122/02, corr. was revised to be brought in line with the requirements of the Note for Guidance on Evaluation of Stability Data (CPMP/ICH/420/02) and the Note for Guidance on Stability Testing of New Drug Substances and Products (CPMP/ICH/2736/99 corr). These changes are: 1. The possibilities to extend the retest period/shelf-life beyond the period of time covered by real-time data by extrapolation are described in more in Annex II with reference to the respective note for guidance 2. 30° C ± 2° C/35 % RH ± 5% RH has been added as a suitable alternative long-term storage condition to 25° C ± 2° C/40 % RH ± 5% RH in section Finished products packaged in semi-permeable containers. 3. The statement on implementation of the change in intermediate storage conditions in the Introductory Note to the Revision of December 2002 has been clarified. Correctio