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Wednesday, September 22, 11:45:00 AM

Pharmaceutical industry is guided by very stringent norms and guidelines that are laid down by FDA and the regulatory bodies. Pharma companies have to follow Good Manufacturing Practice ( GMP ) procedures and guidelines laid down by the regulatory bodies to assure a good quality end product. The ultimate aim of these guidelines is to safeguard the health of consumers by producing good quality medicines or pharmaceutical products. It is mandatory for the pharmaceuticals to comply with GMP and hence, all the pharma companies put a lot of emphasis on quality. Traditional pharmaceutical manufacturing procedures are widely seen as inefficient and inflexible. One of the most essential part of the modern approach to pharmaceutical quality is Quality by design ( QbD) which stands in contrast to the current approach. It places more emphasis on continuous improvement rather than end-product testing. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. The present review covers the essential elements of QbD: target product profile, critical quality attributes, Process Analytical Technology ( PAT) , sources of variability, a formalized risk assessment process, utilization of prior knowledge to design a meaningful experimental approach, formulation design space and process design space.

Date: 09, Sep 2012 Posted By: Kanwalpreet Singh
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