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Long-term stability studies of medicinal products Long-term studies should be carried out in the primary and secondary packaging recommended for the respective medicinal product at a constant upper (the highest) temperature of the specified storage regimen during the entire claimed shelf life.
In some cases, additional tests may be required at the lowest temperature of the specified storage regime (for example, for soft dosage forms, whose physicochemical state may change at low temperatures).
This approach is not applicable for immunobiological medicinal products, such as vaccines, serums, toxins and allergens, for drugs derived from human and animal blood and plasma, as well as for drugs produced using biotechnological processes and methods.
The optimum requirements for primary and secondary packaging and storage conditions are determined based on studies of the medicinal product properties.
is a date of the medicinal product release or the approval of its release in circulation.However, for medicinal products produced by packaging active pharmaceutical ingredients, it should be considered that stability of medicinal products may depend on the remaining shelf life of the active pharmaceutical ingredient used.The residual shelf life means the period of time remaining until the end of the specified shelf life of the medicinal product.Determination of a shelf life is based on a drug stability study using chemical and physicochemical analytical methods specified in general pharmacopoeial articles, as well as, if necessary, other specific study methods, for example, biological methods, pharmacological tests.
The shelf-life of a medicinal product is determined irrespective of the shelf lives of active pharmaceutical ingredients.
It should be also taken into account how the stability of medicinal products is affected by long-term storage of bulk and intermediate products before their transfer from one production area to another or to the packaging area.