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[e-drug] Shelf life of liquid preparations after opening and stability zones

E-DRUG: Shelf life of liquid preparations after opening and stability zones
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Dear e-druggers
 
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.
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1F/Stability_Guideline_WHO.pdf
 
Section 2.2.10 outlines in-use stability testing requirements.
 
Country stability climatic Zones
http://www.who.int/medicines/areas/quality_safety/quality_assurance/StabilityTable2.pdf
 
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.
 
http://www.unicef.org/supply/files/Final_Technical_Requirements_pharma_4th_edition_06.01.2012_AO.pdf
 
http://apps.who.int/prequal/info_general/documents/stability/Stability_Requirements.pdf
 
>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.
 
Kind regards
 
Atieno Ojoo
Technical Specialist, pharmaceuticals
Unicef Supply Division
Unicef Plads, Freeport
2100 Copenhagen
Denmark
Tel; +45 35 27 31 03
Fax: +45 35 26 94 21
Email: atisojoo@yahoo.co.uk
http//www.unicef.org/supply


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