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FDA Compliance

Compliance to Regulations, PAT Initiative Remain Top Market Drivers in European Market

Published: Tuesday, April 22, 2008 - 22:00

(Research and Markets: Dublin, Ireland) – A Frost & Sullivan research service titled “Automation and Control Solutions in the European Pharmaceutical Market” provides an analysis of the various factors driving and restraining the market, revenue forecasts, geographic trends and competitive structure. In this research, Frost & Sullivan’s expert analysts thoroughly examine the following markets: programmable logic controllers (PLC), distributed control systems, supervisory control and data acquisition (SCADA), manufacturing execution systems (MES), human machine interface (HMI), and advanced process control in the European region.

The 21 CFR Part 11 regulation stipulated by the Food and Drug Administration was introduced in 1997. Implemented across Europe through the European Medicines Agency, this regulation requires pharmaceutical companies to increase transparency in their production processes through audit trails and access control functions. By accepting electronic records and electronic signatures as equivalent to paper-based records and handwritten signatures, the FDA paved the way for significant changes in the way that the pharmaceutical industry maintained its records and allowed the industry to leverage technology to keep pace with the fast growth of the industry.

The process analytical technology (PAT) initiative arose from a need felt by the pharmaceutical industry to lower production costs due to pricing pressures. Traditionally, a production process was followed, wherein the quality of the manufactured drug was checked at the end of the process. However, with the PAT initiative, pharmaceutical companies have been able to ensure the quality of their drugs during the production process itself, supporting reduced time to market, reduced costs, and improved quality of products. These two factors are driving growth in the automation and control solutions market due to the scope they present for the use of automation systems such as electronic batch recording systems and analytical equipment, as well as solutions for improving visibility through the production process.

Along with PAT, the MES segment is one of the fastest growing product segments within the automation and control solutions market. MES, which acts as a bridge between the shop-floor automation layer such as PLCs, SCADA/HMI systems and the enterprise level solutions such as enterprise resource planning systems, provides the required visibility through the pharmaceutical production process. MES’s percent share in the overall automation and control solutions in the European pharmaceutical market is expected to be in the range of 20 to 25 percent in 2013.

For more information, visit www.researchandmarkets.com/reports/c88688.


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