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PAT Initiative Expected to Invigorate Pharmaceutical Industry with ...

Source: literature.rockwellautomation.com
Topic: Pharmaceutical Industry

Sort Desciption: Another important driver for PAT is the pressing need within the industry to reduce. production costs and speed time-to-market. Pharmaceutical companies ...

Content Inside: White Paper PAT Initiative Expected to Invigorate Pharmaceutical Industry with Improved Quality, Better Efficiency and Improved Profits. The implementation of Process Analytical Technology (PAT) is bringing real-life benefits and improvements to many pharmaceutical processes. This white paper takes a detailed look at the business drivers of PAT – regulatory and financial – and highlights the fundamental steps to successful implementation. The benefits are lower production cycle times, improved manufacturing efficiency, reduced rejects and increased production uptime. As the United States’ manufacturing sector emerges from one of its most challenging decades in recent memory, pharmaceutical manufacturers are taking a closer look at how they can continue to produce the highest quality products and at the same time generate profit. In addition, the pharmaceutical industry as a whole – with encouragement from the FDA – is seeking to accelerate the pace of manufacturing innovation to meet ever- increasing cost, efficiency and time-to-market demands. While pharmaceutical manufacturers continue to generously allocate funds to research and marketing, the industry as a whole lags behind other automated industries in one key aspect: manufacturing quality analysis. To that end, there is growing enthusiasm in the industry for the many potential gains offered by process analytical technology (PAT), a new FDA initiative that aims to foster improvements in manufacturing efficiency and product quality while creating a harmonization of regulatory expectations. PAT provides a framework for designing, analyzing and controlling manufacturing through timely measurements of raw and in- process materials to help ensure desired product quality. The PAT initiative focuses on the principles of building quality into the product and process, as well as continuous process improvement. The goal of PAT is to encourage the industry to adopt innovative technologies to increas ...

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