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Journal: Indo American Journal of Pharmaceutical Sciences (IAJPS) (Vol.3, No. 2)

Publication Date:

Authors : ; ;

Page : 81-85

Keywords : Impurity Profiling; Regulatory requirements; QbD approach; Critical Quality Attributes; Control Strategy.;

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In this era of competition quality has been given prime magnitude for pharmaceutical product development. Pharmaceutical industries are regulated by various regulatory authorities like ICH, USFDA, Canadian Drug and Health Agency are emphasizing on the purity requirements and the identification of impurities in API’s. Qualification of the impurities is the process of acquiring and evaluating data that establishes biological safety of an individual impurity; thus, revealing the need and scope of impurity profiling of drugs in pharmaceutical research. Quality by Design (QbD) is “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management” and has the aim of improving product quality and of increasing regulatory flexibility. Impurity level is a critical quality attribute for a drug substance or a drug product because levels higher than the toxicologically qualified amount could affect the safety and efficacy of the product. Control of impurities in drug substance and drug product is described in ICH Q3A, Q3B and with thorough product and process knowledge gained from pharmaceutical development under QbD paradigm, an efficient and comprehensive overall impurity control strategy can be developed to achieve the desired quality of the drug substance/ product. Keywords: Impurity Profiling, Regulatory requirements, QbD approach, Critical Quality Attributes, Control Strategy.

Last modified: 2016-03-05 02:42:21