E-DRUG: Shelf life of liquid preparations after opening and stability zones
There is very valuable guidance on Stability from WHO;
WHO stability testing requirements as exemplified in the WHO TRS 953 Annex 2,
acccessed it through ICH website.
Section 2.2.10 outlines in-use stability testing requirements.
Country stability climatic Zones
With reference to stability in specific climatic Zones, National regulatory
authorities can consider to make it a requirement for manufacturers that
register products with them to only register those that meet the stability for
the climatic Zone of the country, unless the API characteristics do not allow,
in which case, special storage instructions will be provided. At UNICEF (and
WHO prequalification), our requirement is for manufacturers to meet Zone IV B
stability requirements unless the product characteristics do not allow.
>From the discussions, there seems to be need for stability studies beyond
>30*C/75%RH and stress tests beyond 40* C/75%RH. Perhaps the academic
>fraternity can start to work on this to begin to generate the data.
Technical Specialist, pharmaceuticals
Unicef Supply Division
Unicef Plads, Freeport
Tel; +45 35 27 31 03
Fax: +45 35 26 94 21