Changes in stability studies testing guidelines from WHO
WHO has recently issued a new set of guidelines for stability testing of pharmaceutical products.
Calculations based on meteorological data have demonstrated that the existing long-term stability conditions in WHO guidelines for Zone IV (30°C/65%RH) do not reflect climatic conditions in many countries, which have hot and very humid areas, such as Brazil, Cuba, China, India and all of the ASEAN countries.
Performing stability studies at more stressful conditions provides an error margin in favour of patient safety and increases the possibility of identifying substances or formulations that create particular stability problems.
Therefore, the climatic Zone IV has now been split into climatic Zone IVa and Zone IVb. The present Zone IV becomes Zone IVa and a new climatic Zone IVb is added to accommodate hot and very humid areas. The new guidelines for stability testing is:
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Zone IVa:
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30°C and 65% RH (hot and humid countries)
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Zone IVb:
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30°C and 75% RH (hot and very humid countries)
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Each individual member state within the former zone IV must indicate towards WHO which of the conditions (zones IVa or IVb), is applicable in its territory. WHO will make this information easily accessible to third parties on an international basis.
The storage conditions of pharmaceutical products recommended by the manufacturers on the basis of stability studies should guarantee the maintenance of quality, safety and efficacy throughout the shelf-life of a product. Special consideration must be made to the effect on products of the extremely adverse climatic conditions in certain countries to which the products may be exported.
As a consequence of the new WHO stability testing guidelines and the relations for storing, Missionpharma has decided to change the storage conditions on product labels from “Store in a cool and dry place away from light” to the more specific "Store at temperature not exceeding 30ºC in a dry place. Protect from light."
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