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This article has been distributed by: http://Article-Distribution.com Helpful Link: The Digital Millennium Copyright Act - Overview http://www.gseis.ucla.edu/iclp/dmca1.htm --------------------------------------------------------------------- Article Title: ============== Quality by Design Streamlines Pharmaceutical Manufacturing Article Description: ==================== The pharmaceutical industry wastes more than $50 billion a year in manufacturing costs according to findings of a study conducted jointly by Olin School of Business at Washington University and McDonough School of Business at Georgetown University. The goal of the study was to understand how the FDA regulates pharmaceutical production and how those regulations may be inhibiting advances in manufacturing. Quality by Design ensures reduced deficiencies, quicker approvals, and improved interaction with FDA. It also allows for continuous improvements in products and manufacturing process, as well as a better understanding of how APIs and excipients affect manufacturing. Additional Article Information: =============================== 453 Words; formatted to 65 Characters per Line Distribution Date and Time: 2008-06-24 11:12:00 Written By: Norm Howe Copyright: 2008 Contact Email: mailto:[EMAIL PROTECTED] Norm Howe's Picture URL: http://vcillc.com/about.html For more free-reprint articles by Norm Howe, please visit: http://www.thePhantomWriters.com/recent/author/norm-howe.html ============================================= Special Notice For Publishers and Webmasters: ============================================= If you use this article on your website or in your ezine, We Want To Know About It. Use the following URL to let us know where you have used this article, and we will include a link to your website on thePhantomWriters.com: http://thephantomwriters.com/notify.php?id=6141&p=load HTML Copy-and-Paste and TEXT Copy-and-Paste Versions Of Article Are Available at: http://thePhantomWriters.com/free_content/db/h/streamlines-pharmaceutical-manufacturing.shtml#get_code --------------------------------------------------------------------- Quality by Design Streamlines Pharmaceutical Manufacturing Copyright (c) 2008 Norm Howe Validation and Compliance Institute http://www.vcillc.com The pharmaceutical industry wastes more than $50 billion a year in manufacturing costs, this according to findings of a study on the interplay of pharmaceutical manufacturing and the Food and Drug Administration (FDA). The study, conducted jointly by Olin School of Business at Washington University and McDonough School of Business at Georgetown University, received no funding from either the pharmaceutical industry or the FDA. The goal of the study was to understand how the FDA regulates pharmaceutical production and how those regulations may be inhibiting advances in manufacturing. The study looked at data collected from 42 manufacturing facilities owned by 19 manufacturers, in particular each company?s manufacturing performance in terms of cycle time, frequency of deviations, reasons for deviations, yield, and improvement rates on key manufacturing metrics. The outcome identified two factors that could be assisted by Quality-by-Design. First, companies using information technology to electronically track and report on manufacturing and centrally stored all their data displayed superior manufacturing performance relative to those not using such information technology. Second, the ability of employees in lower ranks to make decisions directly correlated to gains in manufacturing performance, particularly regarding deviation management, lot failure, lot review and process validation. The FDA?s Quality by Design (QbD) initiative has shifted quality control from a static end result to an ongoing, evolving entity?one that tracks a product from inception to creation, rather than looks only at the final product. The QbD initiative, which originated from the Office of Biotechnology Products (OBP), attempts to provide guidance on pharmaceutical development to facilitate design of products and processes that maximizes the product?s efficacy and safety profile while enhancing product manufacturability. Fundamental to this initiative is the understanding of the relationship between the quality attributes of the product (physicochemical and biological properties) and their impact on the safety and efficacy. This requires knowledge of the relationship between structure and biological functions. In short, QbD is a scientific, risk-based, holistic and proactive approach to pharmaceutical development, as well as deliberate design effort from product conception through commercialization. QbD offers a full understanding of how product attributes and process relate to product performance. The initiative benefits everyone by ensuring better design of products with less problems in manufacturing. It also reduces the number of manufacturing supplements required for post market changes, and allows for implementation of new technology to improve manufacturing without regulatory scrutiny, as well as possible reduction in overall costs of manufacturing. QbD ensures reduced deficiencies, quicker approvals, and improved interaction with FDA. It also allows for continuous improvements in products and manufacturing process, as well as a better understanding of how APIs and excipients affect manufacturing. Lastly, it relates manufacturing to clinical during design, and provides a better overall business model. --------------------------------------------------------------------- Norm Howe, Senior Partner at Validation and Compliance Institute, consultants for the pharmaceutical and medical device industries. He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA. He has held many management positions in FDA regulated industries, most at BASF. http://www.vcillc.com --- END ARTICLE --- Get HTML or TEXT Copy-and-Paste Versions Of This Article at: http://thePhantomWriters.com/free_content/db/h/streamlines-pharmaceutical-manufacturing.shtml#get_code ..................................... 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