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  • Global Climatic Zone Divisions For Stability Studies On Pharmaceuticals

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    Pardeep Saini
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    The document discusses global climatic zone divisions for stability testing of pharmaceuticals. It notes that while drugs may be manufactured in one location, they can be consumed in markets around the world with varying climatic conditions. To account for this, the International Conference on Harmonisation recommended classifying the world into five climatic zones (I-IVa/IVb) based on temperature and humidity levels. The zones help determine appropriate long-term stability testing conditions and expected shelf life for drugs in different parts of the world, with warmer zones likely having shorter shelf lives due to faster product degradation.

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    Global climatic zone divisions

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    Global climatic zone divisions for stability studies on pharmaceuticals - Lab-Training.com

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    The document discusses global climatic zone divisions for stability testing of pharmaceuticals. It notes that while drugs may be manufactured in one location, they can be consumed in markets around the world with varying climatic conditions. To account for this, the International Conference on Harmonisation recommended classifying the world into five climatic zones (I-IVa/IVb) based on temperature and humidity levels. The zones help determine appropriate long-term stability testing conditions and expected shelf life for drugs in different parts of the world, with warmer zones likely having shorter shelf lives due to faster product degradation.

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    © All Rights Reserved
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    42 views2 pages

    Global Climatic Zone Divisions For Stability Studies On Pharmaceuticals

    Uploaded by

    Pardeep Saini
    The document discusses global climatic zone divisions for stability testing of pharmaceuticals. It notes that while drugs may be manufactured in one location, they can be consumed in markets around the world with varying climatic conditions. To account for this, the International Conference on Harmonisation recommended classifying the world into five climatic zones (I-IVa/IVb) based on temperature and humidity levels. The zones help determine appropriate long-term stability testing conditions and expected shelf life for drugs in different parts of the world, with warmer zones likely having shorter shelf lives due to faster product degradation.

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    © All Rights Reserved
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    Global climatic zone divisions for stability


    studies on pharmaceuticals

    Dr. Deepak
    2 Comments
    November 20, 2017

    A pharmaceutical
    manufacturer has
    manufacturing
    facilities in single or
    multiple locations.
    However, the
    product can be
    consumed by
    patients at locations
    which can be spread
    World Climatic zones
    within the country or
    even in markets
    across the world. It is natural to expect variations in climatic conditions in
    different locations so the question arises that will the shelf life be same or
    different in domestic and international markets.

    For the purpose of stability testing ICH recommended the world climate into
    four zones, namely, I,II,III ad IV. The zone IV was subsequently split into zone
    IVa and IVb. The temperature and long term testing conditions for the four
    zones are mentioned below. The degradation of the product will be faster in
    higher category zones so the shelf life will be shorter in such areas.

    Climate Zone  Temperature  Humidity

    I-Temperate 210 C + / 20 C 45% +/- 5%RH


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