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Assessing FDA's risk methodology at pharmaceutical manufacturing sites
by Warren Adis
International Journal of Business Continuity and Risk Management (IJBCRM), Vol. 1, No. 3, 2010

 

Abstract: This research analyses the US Food and Drug Administration's (FDA's) risk methodology used for inspecting pharmaceutical manufacturing sites. It reviews the procedures, regulations, and violations specified in FDA warning letters (WLs). In particular it focuses on the time period between 2004-2009, as the FDA transitioned and formalised this new approach to site inspections. One of the principal outcomes of this study is to gauge the FDA's performance and assess its new methodology.

 

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