Quality System Management for Process Analytical Technology Applications
Nieves Mercado, Deborah E.
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Commonly the pharmaceutical industry uses a system known as the traditional or conventional process for the manufacturing of their products. Now, it has been shown that the use of other systems not only benefits in product quality, but also on cost-effective and process efficiency. This is why the Food and Drug Administration has initiated a revolutionary campaign to encourage the industry on implementing new system upgrades. Process Analytical Technology or PAT is a set of tools that will provide with better understanding and control of the process. Some of the benefits provided by the technology revolve in the reduction of production costs by reducing cycle-time and the overhauling of the process for making it more ecofriendly. Both techniques have unique characteristics, but is important to highlight this improvements to the manufacturing process in order to provide us with high quality products in our quest for better quality of life. Key Terms - Analytical Process, Food and Drug Administration, Process Analytical Technology, Traditional Pharmaceutical Manufacturing Process.