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Abstract

Quality of pharmaceuticals has always important area of concern for regulatory agencies across the globe in order to maintain the quality and facilitate production of pharmaceutical preparation without batch to batch variations and hence maintaining the same therapeutic effectiveness with the advent of total quality management a new vista has opened for assured quality of pharmaceuticals. Total quality management being a multidimensional approach essentially requires adherence to quality practices in all areas of pharmaceutical production. Application of various approaches and practices viz. quality by design, quality risk management, six sigma approach along with following regulatory guidelines in all facets may lead to practical realization of this concept. This article presents a brief review of existing industrial practices of total quality management with special emphasis on recent advancements as well as importance of TQM in Pharmaceutical Production.

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