Adoption and Reasons for Withdrawal of ICH Q1F Guidelines

    Published on:August 2016
    Journal of Young Pharmacists, 2016; 8(4):500-504
    Short Communication | doi:10.5530/jyp.2016.4.31
    Authors:

    Siddharth Jadeja1, Girish Pai Kulyadi2 and Muddukrishna Badamane Sathyanarayana1*

    1Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal-576104, Karnataka, INDIA.

    2Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal-576104, Karnataka, INDIA.

    Abstract:

    ICH Q1 F guideline provided astability data package for the registration applications of drug substance and drug product in Climatic Zones III (hot and dry) and IV (hot and humid). These guidelines were adopted by the ICH in February 2003 and subsequently implemented in the ICH regions. Due to some reasons the guidelines were withdrawn. This review article describes the development of the concept of the climatic zones, the introduction of the guideline Q1F, its adoption, objections to these guidelines, its withdrawal and reasons for the withdrawal and its alaternative that was proposed.

    Key words: Guidelines, ICH, Q1F, Stability, Withdrawal.

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