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  • Stability: Studies 179

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    Stability testing guidelines in major drug producing countries like the European Community, Japan, and the United States are generally consistent in basic principles but formal requirements vary between jurisdictions. Harmonizing these guidelines could establish standards acceptable to many countries by building on shared principles and addressing differences. The proposed harmonized guidelines would cover 83% of the global drug market and be adopted by other regions like Canada and Australia. Stability testing during drug development generates comprehensive results over multiple stages to establish reliable information on product stability.

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    Stability testing guidelines in major drug producing countries like the European Community, Japan, and the United States are generally consistent in basic principles but formal requirements vary between jurisdictions. Harmonizing these guidelines could establish standards acceptable to many countries by building on shared principles and addressing differences. The proposed harmonized guidelines would cover 83% of the global drug market and be adopted by other regions like Canada and Australia. Stability testing during drug development generates comprehensive results over multiple stages to establish reliable information on product stability.

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    6 views1 page

    Stability: Studies 179

    Uploaded by

    lolyyyoop
    Stability testing guidelines in major drug producing countries like the European Community, Japan, and the United States are generally consistent in basic principles but formal requirements vary between jurisdictions. Harmonizing these guidelines could establish standards acceptable to many countries by building on shared principles and addressing differences. The proposed harmonized guidelines would cover 83% of the global drug market and be adopted by other regions like Canada and Australia. Stability testing during drug development generates comprehensive results over multiple stages to establish reliable information on product stability.

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    STABILITY STUDIES 179

    extended. As a result, the stability information is based on all of


    the results obtained during development.
    Nearly all of the countries where drugs are produced have their
    own guidelines. Stability testing guidelines in the European
    Community (EC), Japan, and the United States show no significant
    differences in the basic principles listed below.
    Stability testing during drug development
    Selection of batches and samples
    Test criteria
    Analytical methods
    Specifications
    Storage conditions
    Test intervals
    Storage period
    Number of stability batches
    Packing materials
    Evaluation of data
    However, formal requirements do vary. It would be very
    desirable to elaborate on the basic principles and demonstrate the
    importance of formal differences. On the basis of the discussions
    of these differences, harmonized guidelines can be developed that
    are acceptable to a large number of countries.
    The aim of these guidelines is to present state-of-the-art
    stability testing, including the latest official requirements in the
    EC, Japan, and the United States, and to indicate future prospects
    in stability testing. The harmonized guidelines in these three areas
    will cover 83% of the world market for drug products. These
    guidelines will be adopted by Canada and Australia, and a number
    of other countries are sure to follow.
    Stability Testing During Drug Development
    Comprehensive and reliable stability information is based on a
    large number of individual results generated during development of
    a drug product. The individual stages during development should
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