Academic journal article Communications of the IIMA

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

Academic journal article Communications of the IIMA

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

Article excerpt


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.


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). …

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