This paper will focus on the technological developments that are driving the pharmaceutical industry. Governmental oversight imposed by the Food and Drug Administration requires strict accountability and quality control. We will look to the fast food industry for best practices considering the FDA also regulates this industry as well. A repeatable and auditable system of production, operation, and distribution will be the cornerstones of the technology employed.
The pharmaceutical industry is a highly regulated industry that is subject to continuous audits and monitoring form the government. The regulatory oversight to assure that the drug products meet the identity, strength, quality, and purity regulations begins with manufacturing of the investigational drug for its first use in human subjects and continues through the shelf life of the product (Velagaleti, Burns & Gill, 2003). Automation is one of the tools being used by the industry to minimize costs while complying with these regulations. In the beginning the Food and Drug Administration, FDA, government agency that regulates the industry, was very concerned on the effect that automation and cost reduction could have on the final product. This led to the review of the Code of Federal Regulations to regulate how to automate processes. The industry has invested a great deal of effort in demonstrating that automation, if handled correctly, does not jeopardize the final product or the consumers’ safety.
Complying with the regulations and fully automating requires an interaction between the SCADA, PLC, network, databases, servers and reporting tools. Supervisory Control and Data Acquisition (SCADA), as the name indicates, is not a full c...
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CitectSCADA helps control quality for McDonald's suppliers. (2004). My Citect News,
Retrieved Oct 09, 2005, from http://www.citect.com/mycitectnews/?p=597
Danees & Salter (2003). What is a SCADA? Retrieved on October 08, 2005 from http://ref.web.cern.ch/ref/CERN/CNL/2000/003/scada/
Office of Pharmaceutical Science (2005). Process Analytical Technology (PAT) Initiative. Retrieved on October 08, 2005 from http://www.fda.gov/cder/OPS/PAT.htm
Velagaleti, Burns & Gill (2003). Analytical Support for Drug Manufacturing in the United States-from Active Pharmaceutical Ingredient Synthesis to Drug Product Shelf Life. Drug Information Journal 37(4) 407. Retrieved on October 08, 2005 from ProQuest Database.
Vijavan (2000). Manufacturing Execution Systems. Retrieved on October 08, 2005 from http://www.computerworld.com/industrytopics/retail/story/0,10801,47639,00.html
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