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Pharmaceutical Industry in Transition

Source: www.isa.org
Topic: Pharmaceutical Industry

Sort Desciption: compliance in the pharmaceutical industry. The market is shifting the integration. requirements from hardware to software ...

Content Inside: T HOUGHT L EADERS FOR M ANUFACTURING & S UPPLY C HAIN ARC INSIGHTS By John Blanchard & Sal Spada I NSIGHT # 2003-19MD&H M AY 7, 2003 Modern packaging technology and controls will play an increasingly important role in manufacturing performance and regulatory compliance in the pharmaceutical industry. The market is shifting the integration requirements from hardware to software while improving the overall reliability and flexibility of solutions. Pharmaceutical Industry in Transition Keywords Pharmaceutical, Packaging Machinery, 3 rd Generation Controls Summary The pharmaceutical business is in transition as the formula for success rely- ing solely upon new drug development and time to market is being challenged. Global competition, reduced patent protection, the rising cost of drug development, socio-political pressure for more affordable and available life saving drugs, and FDA initiatives require a business model placing greater emphasis on Good Manufacturing Practices (GMPs) and manufacturing performance. Manufacturing efficiency and evolving regulatory requirements demand the employment of best practices. Cost and time to validation still play a critical role in time to market and potential loss of millions of dollars of revenue, but manufacturing perform- ance and compliance with GMPs have become critical to business success and even business survival. Analysis Manufacturing is playing an important role in meeting the global demand for safer, affordable, and available life saving drugs. Modern packaging machinery plays an important part in achieving optimal manufacturing performance and regulatory compliance. Packaging machinery also plays a critical part in reducing time to market, increasing production capacity, responding to changing consumer demand, ensuring product quality and safety issues, increasing product convenience as well as product brand identification. According to the FDA, at least 30 percent of medical errors resulting in ...

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