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THE PHARMA REVIEW (MAY JUNE 2016)

Quality By Design (QbD) A Key in Quality Assurance of Pharmaceuticals: A Review

Santosh V. Gandhi & Shreeyash R. Tapale

Introduction: In this era of competition, quality has been given prime importance; failure to meet such quality related goals produces massive loss. Quality means fitness for intended use. Quality by design (QbD) is an essential part of the modern pharmaceutical industry. QbD is best way to build a quality in all pharmaceutical products. The pharmaceutical 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 while quality assurance is a wide ranging concept, covering all matters that collectively or individually affect the quality of product. It is totality of arrangement made with objective to ensure that pharmaceutical products are of required quality for their intended use. QbD is a novel concept which offers pharmaceutical manufacturer with increased self-regulated flexibility while maintaining tight quality standards and real time release of the drug product. The base of Quality by design is International conference on harmonization (ICH) guidelines Q8 for Pharmaceutical for development, Q9 quality risk management, Q10 for pharmaceutical quality systems. In this review the quality by design is described in brief and some of its elements are identified. 

 

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