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Risk assessment & management in pharmaceutical industries: Vital requirement to ensure product quality

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Author(s): Huma Ali *1 and Rajesh Hajela 2

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 4;
Issue: 6;
Start page: 1909;
Date: 2011;
Original page

Keywords: Risk assessment | risk management | risk control | risk communications | pharmaceutical safety.

ABSTRACT
Risk assessment is science-based, systematic, identifies specific hazards and measures for their control, as well as providing information on environmental protection and labor safety. The purpose of risk assessment is effects of every process laid down in the different requirement stages should be investigated andassessed in order to guarantee perfect product that comply with the specifications and GMP norms. The present article is aimed at assisting industry to provide, develop and implementation effective HACCP or risk assessment strategy covering activities such as research and development, sourcing of materials, manufacturing,packaging, testing and distribution for direct and indirect effects on the product quality. We should encourage open risk aware culture to understand risk always exist and to identify opportunities for improvement.
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