Risk identification for quality on stage of pharmaceutical development of combined eye drops for glaucoma treatment
DOI:
https://doi.org/10.15587/2313-8416.2015.56944Keywords:
drug, pharmaceutical development, QbD, critical quality attribute, risk assessment, CH Q9Abstract
Aim: To identify the possible risks associated with critical quality attribute of combined eye drops for the treatment of glaucoma using of common risk evaluation methodologies for plannig a drug quality on the stage of pharmaceutical development.
Methods: The paper used method of causal analysis. The maximal number of factors has been define to identify potential factors that provide most significant impact on the drug quality and Ishikawa diagram - graphical representation of causes and effects has been built.
Results: Analysis allowed to organize the possible factors affecting the drug quality in the generalized categories: quality control methods, medicines and excipients, primary packaging, proper manufacturing conditions and the stage of the process. The most important factors that are carriers of the risk factors and may lead to negative effects have been identified for the generalized categories.
Conclusions: Determined at the stage of pharmaceutical development potential critical quality attribute of AFI, excipients and primary packaging, critical parameters of the process, provide a better understanding, reduction and adoption of risk in subsequent stages of the life cycle of the drug
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Copyright (c) 2015 Олександр Миколайович Якубчук, Світлана Володимировна Русанова, Олена Геннадіївна Фетісова, Лариса Миколаївна Андрюкова, Володимир Костянтинович Яковенко
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