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UNDERSTANDING INDUSTRIAL PRACTICES FOR PHARMACEUTICAL QUALITY MANAGEMENT- II, PROCESS VALIDATION

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Manufacturing of quality pharmaceuticals still remains a quest to achieve on a global platform. Application of total quality management practices at industrial level has paved the path to attain pharmaceutical quality with an approach of in built quality. Apart from other strategies of quality management, process validation is an essential requisite for quality control and assurance. The basic principle of pharmaceutical process validation is to obtain quality product that is fit for intended use. Being an integrated part of quality management system, it is a critical tool for cost effective, safe and efficacious product with predetermined quality characteristics. This article gives an overview of different aspects of process validation in pharmaceutical sector like its significance need, types, various approaches and tools with special emphasis on its practical execution and implementation for a representative dosage form i.e. tablets.
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