Analysis of FDA's Risk Assessment Methodology at Pharmaceutical Manufacturing Sites

By Adis, Warren | Communications of the IIMA, January 2009 | Go to article overview

Analysis of FDA's Risk Assessment Methodology at Pharmaceutical Manufacturing Sites


Adis, Warren, Communications of the IIMA


U.S.A. FOOD AND DRUG ADMINISTRATION

This paper outlines an initial investigation of the FDA's new risk methodology as it is applied to the manufacturing sector of the bio-pharmaceutical (BP) industry. The research reviewed FDA regulations concerning quality assurance, the corresponding procedural manuals, as well as, examining the violation warning letters issued by the FDA from 2004 to 2008. This research will serve as the basis for developing a more formal research proposal to study in-depth changes in the FDA as well as the BP industry.

In 2004, the FDA announced that its oversight of the BP industry would incorporate a risk-based methodology in its inspection of manufacturing processes. In the almost 5 years between the 2004 announcement and 2008, questions have arisen as to how this decision has impacted the FDA oversight process, in terms of manufacturing sites inspected, types of observations completed at each site, and outcomes of these inspections. Knowing this information is basic to understanding how risk methodology is incorporated into manufacturing site visits on one hand, and on the other how successful this new approach has been for the FDA (Adis, 2007). This study gathered data from site visits, categorized the number and type of annual manufacturing inspections, and examined the frequency and type of violations detailed in the warning letters issued to manufacturers. As far as evaluating the success of this new approach, the data looked at the FDA's performance and whether it has been more capable of finding violations in the inspection process, and better at providing directions and guidance to manufacturers during this time period.

Gathering this information is both a significant and complex task, considering the thousands of inspections that occur at diverse manufacturing facilities around the country. Yet this task has been made somewhat easier by the Freedom of Information Act which makes important data available to researchers and the BP community. The problem quickly becomes that of sorting through the vast amount of information available at the FDA web site, which details the full operation of the Agency. Therefore, the researchers made the decision to focus on one particular subset within the BP industry--that of medical device manufacturers. Within this industry subset, the research then established benchmark indicators showing how the risk methodology has been incorporated into the FDA current Good Manufacturing Practices (cGMP). Specifically this paper reviews and analyzes how quality assurance and CAPA risk methodology (as detailed in FDA regulation 820.100) is incorporated within the FDA rubric of cGMP. CAPA is a critical component in measuring risk, since problem containment and remediation are intrinsic in determining the outcome (COSO, 2004).

The choice of focusing on one FDA cGMP sector--that of medical device manufacturing--enables a comparison to be made between similar manufacturing sites, while using the same FDA inspection methodologies. Therefore it becomes easier to judge how the FDA incorporates CAPA and quality assurance in its emphasis on manufacturing excellence. This research provides an initial cut at evaluating the risk methodology and providing measurement data to determine how and with what success the Agency performs its oversight function.

FDA'S CURRENT GOOD MANUFACTURING PRACTICES METHODOLOGY

The main objective of the FDA is to ensure public safety through establishing industrial quality standards, benchmarks and vigorous oversight. Its role is that of principal supervisory Agency, assuring that industry best practices are followed (GAMP, 2001) in the research, development and manufacturing life cycle of drugs, vaccines, other biological products, and medical devices. Its tasks are to inspect sites, examine products and processes, issue warning letters, and order recalls. The exceptionally low tolerance for variability or deviation in quality pharmaceutical products is built around its compliance guidelines (FDA, 2003a; FDA, 2004a). …

The rest of this article is only available to active members of Questia

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

(Einhorn 25)

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Note: primary sources have slightly different requirements for citation. Please see these guidelines for more information.

Cited article

Analysis of FDA's Risk Assessment Methodology at Pharmaceutical Manufacturing Sites
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Help
Full screen
Items saved from this article
  • Highlights & Notes
  • Citations
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA 8, MLA 7, APA and Chicago citation styles.

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

    1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

    Cited passage

    Thanks for trying Questia!

    Please continue trying out our research tools, but please note, full functionality is available only to our active members.

    Your work will be lost once you leave this Web page.

    Buy instant access to save your work.

    Already a member? Log in now.

    Search by... Author
    Show... All Results Primary Sources Peer-reviewed

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.