Storage condition tolerances The acceptable variations in temperature and

Storage condition tolerances the acceptable

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that a drug product should meet throughout its shelf life. Storage condition tolerances: The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies. The equipment should be capable of controlling the storage condition within the ranges defined in this guidance. The actual temperature and humidity (when controlled) should be monitored during stability storage. Short-term spikes due to opening of doors of the storage facility are accepted as unavoidable. The effect of excursions due to equipment failure should be addressed and reported if judged to affect stability results. Excursions that exceed the defined tolerances for more than 24 hours should be described in the study report and their effect assessed. Stress testing (drug product): Studies undertaken to assess the effect of severe conditions on the drug product. Such studies include photostability testing (see ICH Q1B) and specific testing of certain products (e.g., metered dose inhalers, creams, emulsions, refrigerated aqueous liquid products). Supporting data: Data, other than those from formal stability studies, that support the analytical procedures, the proposed retest period or shelf life, and the label storage statements. Such data include (1) stability data on early synthetic route batches of drug substance, smallscale batches of materials, investigational formulations not proposed for marketing, related formulations, and product presented in
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containers and closures other than those proposed for marketing; (2) information regarding test results on containers; and (3) other scientific rationales. Degradation Product: An impurity resulting from a chemical change in the drug substance brought about during manufacture and/or storage of the new drug product by the effect of, for example, light, temperature, pH, water, or by reaction with an excipient and/or the immediate container closure system Degradation Profile: A description of the degradation products observed in the drug substance or drug product Development Studies: Studies conducted to scale-up, optimize, and validate the manufacturing process for a drug product Identification Threshold: A limit above (>) which a degradation product should be identified Identified Degradation Product: A degradation product for which a structural characterization has been achieved Impurity: Any component of the new drug product that is not the drug substance or an excipient in the drug product Impurity Profile: A description of the identified and unidentified impurities present in a drug product New Drug Substance: The designated therapeutic moiety that has not been previously registered in a region or member state (also referred to as a new molecular entity or new chemical entity). It can be a complex, simple ester, or salt of a previously approved substance. Qualification: The process of acquiring and evaluating data that establishes the biological safety of an individual degradation product or a given degradation profile at the levels specified Qualification Threshold: A limit above (>) which a degradation product should be qualified Reporting Threshold: A limit above (>) which a degradation product should be reported Specified Degradation Product: A degradation product that is individually listed and limited with a specific acceptance criterion in the new drug product specification. A specified degradation product can be either identified or unidentified Unidentified Degradation Product: A degradation product for which a structural characterization has not been achieved and that is defined solely by qualitative analytical properties (e.g., chromatographic retention time) 1 Contains Nonbinding Recommendations Unspecified Degradation Product: A degradation product that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion, in the new drug product specification
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  • Fall '16
  • Pharmacology, Chemical reaction, drug product, New chemical entity, drug substance

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