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.

Online publication date: Sat, 02-Oct-2010

The full text of this article is only available to individual subscribers or to users at subscribing institutions.

 
Existing subscribers:
Go to Inderscience Online Journals to access the Full Text of this article.

Pay per view:
If you are not a subscriber and you just want to read the full contents of this article, buy online access here.

Complimentary Subscribers, Editors or Members of the Editorial Board of the International Journal of Business Continuity and Risk Management (IJBCRM):
Login with your Inderscience username and password:

Username:        Password:          Forgotten your password?

Want to subscribe?
A subscription gives you complete access to all articles in the current issue, as well as to all articles in the previous three years (where applicable). See our Orders page to subscribe.

If you still need assistance, please email subs@inderscience.com