Transcription of Stability Testing of Pharmaceutical Products in a …
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Regulatory FeatureThe Stability of finishedpharmaceutical productsdepends onenvironmental andproduct-related factorsICH and WHO starteddiscussions in 2000 toharmonise the number ofstability tests andconditions there was littleagreement frominterested parties on anICH proposal regardinglong-term storageconditions in zone IV(hot and humidcountries) Stability Testing of PharmaceuticalProducts in a Global EnvironmentDr Sabine Koppreports on the development of World HealthOrganization policy on Stability lengthy discussions, the World Health Organization (WHO) has revised its guidelines onstability Testing conditions for climatic zone IV, ie hot and humid countries. The guidelines areexpected to be made available shortly. This article summarises the key events that have marked theWHO s work on developing international Stability Testing guidelines.
Regulatory Feature In 2001, in a further round of discussions, it was proposed to change the real-time storage conditions for zone IV from 30°C and 70% RH to 30°C and 65% RH.
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