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Quality by Design Streamlines Pharmaceutical ManufacturingCopyright © 2008 Norm HoweThe 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. About The Author:
*** Digital Reprint Rights *** *** Author Notification *** We ask that you notify the author of publication of his or her work. Norm Howe can be reached at: info@vcillc.com *** Print Publication Reprint Rights *** If you desire to publish this article in a PRINT publication, you must contact the author directly for Print Permission at: info@vcillc.com
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