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September 26, 2006
Quality Assurance Staffing Ratios: Metrics Show Best RBA Implementation
Research suggests RDA may require large, upfront commitment of resources
CHAPEL HILL, N.C., September 26, 2006 – The highly competitive nature of the pharmaceutical and biotech industries has left companies striving to allocate their staffing resources in the most efficient manner. A recent study by research and consulting firm Best Practices, LLC benchmarked the application of the Risk-Based Approach in preparing for upcoming FDA inspections.
There were six participants in the study, including pharmaceutical giants Novartis and Eli Lilly. “Metrics for Quality Assurance and Risk-Based Approach,” available at http://www.best-in-class.com/br91.htm offers a detailed analysis on optimal QA staffing ratios by function, including GMP, GLP, GCP, Pharmacovigilance QA, API, and Inspections Administration. This study also shows the average percentage of R&D activities that are outsourced.
Among the key findings in the study show that little evidence exists supporting a correlation between the level of formality of Risk-Based Approach implementation and QA to R&D activity staffing ratios. This may indicate that Risk-Based Approach requires a large up-front commitment of resources that affects efficiency and that many companies have not had formal RBA in place long enough to realize such efficiencies.
Because of the need for such an upfront commitment and demand, Best Practices, LLC found that most study respondents characterized their implementation of Risk Based Approach in different QA areas as “under development.” With that said, many already are seeing the benefits of this FDA initiative. It has helped companies to:
• Better understand the FDA’s expectations for compliance with Part 11.
• Effectively identify problems that would cause material waste, and has helped QA managers to identify cost-avoidance opportunities.
• Understand where to send their auditors.
• Identify and prepare likely candidates for regulatory audits. These candidates subsequently performed well in FDA audits.
Some key research findings include:
· The benchmarked companies have about 4,000 to 6,000 R&D FTEs, with an average ratio of QA organization size relative to the R&D functions they serve at 1:34.
· For 83 percent and 66 percent of the benchmark partners, respectively, GLP and GMP risk-based approach levels of application are still “under development.”
· The level of outsourced clinical research varies from company to company, ranging from 10 percent of total research outsourced to 80 percent.
“Metrics for Quality Assurance and Risk-Based Approach” reflects the type of research Best Practices, LLC conducts for members of its Business Excellence Board (http://www.best-in-class.com/beb), a research and advisory service for health care and pharmaceutical executives.
For information on other services by Best Practices, LLC and its Business Excellence Board, contact Cameron Tew at ctew@best-in-class.com or (919) 767-9246.
BEST PRACTICES, LLC is a research and advisory services firm that conducts work based on the principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies. For more information, call (919) 403-0251 or visit www.best-in-class.com.
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