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UNDERSTANDING INDUSTRIAL PRACTICES FOR PHARMACEUTICAL QUALITY MANAGEMENT- I, EXISTING APPROACHES AND GUIDELINES

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Abstract (2. Language): 
Quality pharmaceuticals have always been a quest for industries worldwide due to serious concern about safety, efficacy and purity. In view of this, regulatory agencies across the globe have implemented various stringent guidelines to ensure production of pharmaceutical products with assured quality. In order to fulfil norms and implement “quality” concept, pharmaceutical industries have applied a number of quality management approached like total quality management, quality-by-design and six-sigma etc. Despite of these industrial practices, these approaches and guidelines are not clear till date for beginners. The focus of present article is to understand roles of drug regulatory authorities, various steps involved in discovery of a new drug and corresponding guidelines for medicinal product along with to provide an overview of existing approaches for quality management of pharmaceuticals.
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