Assessing FDA's risk methodology at pharmaceutical manufacturing sites

Author: Adis, Warren

Source: International Journal of Business Continuity and Risk Management, Volume 1, Number 3, 2 October 2010 , pp. 259-270(12)

Publisher: Inderscience Publishers

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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.

Keywords: MANAGEMENT AND BUSINESS; Business Administration; ENERGY AND ENVIRONMENT; Infrastructures; RISK, SAFETY AND EMERGENCY MANAGEMENT; Risk, Reliability and Safety; Security and Emergency Management

Document Type: Research article

DOI: http://dx.doi.org/10.1504/IJBCRM.2010.035689

Affiliations: 1: Hagan School of Business, Iona College, New Rochelle, NY, USA

Publication date: 2010-10-02

More about this publication?

The International Journal of Business Continuity and Risk Management is a refereed international journal that provides a professional and scholarly forum in the essential field of business continuity and risk management with particular emphasis on decision making using a multidisciplinary approach. Organisational resiliency through risk assessment, contingency planning, systems security, crisis and disaster management, and recovery planning, as well as public policy regarding infrastructure and security, are integrated in the journal's coverage.