Compliance to Regulations and the PAT Initiative Remain Top Market Drivers in the European Pharmaceutical Market
Research and Markets (http://www.researchandmarkets.com/reports/c88688) has announced the addition of “Automation and Control Solutions in the European Pharmaceutical Market” to their offering.
The 21 CFR Part 11 regulation stipulated by the Food and Drugs Administration (FDA) was introduced in 1997. Implemented across Europe through the European Medicines Agency (EMEA), 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. “Compliance to various regulations such as 21 CFR part 11 and Current Good Manufacturing Practices (cGMP) put forth by the FDA remains a major factor propelling growth in the automation and control solutions market,” comments the analyst of this research. “At the same time, operational efficiency, in terms of bringing down production costs, reducing time to market and increasing flexibility in production, is also a strategic reason for pharmaceutical companies to invest in automation solutions.”
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, analytical equipment as well as solutions for improving visibility through the production process.