Pharmaceutical Plant Benchmarks

Industrial Management Consulting
Industrial Management Consulting

The Pharmaceutical Industry encompasses complex and diverse operations with highly specialized tools — grinders, mixers, granulators, cell culture equipment, filtration systems, bioreacators, filling machines, packaging systems — that require advanced technical expertise. Plants take drug
and process design requirements from formulation scientists and transfer those chemical and/or biologic specifications into unique operations that deliver reliable, high-quality medicines.
It can take more than a decade for a drug to undergo preclinical and clinical testing, requiring millions of dollars to receive FDA approval before full-scale production can begin. After launch, pharmaceutical
plants are subject to intense scrutiny from the FDA, which monitors compliance with Current Good Manufacturing Practice (CGMP) regulations (i.e., minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packaging of a drug).2Total global medicine spending is projected to reach $1.3 trillion in 2018, an increase of approximately $300 billion from 2013, driven by population growth, an aging population, and improved access to healthcare in
emerging markets. Not surprisingly, the largest per capita spending increase will be in the United States.

This increased demand has contributed to an increase in the number of U.S. pharmaceutical and
medicine production facilities, from 1,833 establishments in 2004 to 2,177 in 2014.4 Along with this growth, heightened regulatory oversight and cost pressures compel industry executives to pursue process improvements and competitive benchmarks, including:

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