Performance Improvement 2005. Risk-based Method for Prioritizing Current Good Manufacturing Practices Inspections of Pharmaceutical Manufacturing Sites- a Pilot Risk Ranking Model


The study examined the use of a risk-based model to select drug establishments for inspection. The Federal Food, Drug, and Cosmetic Act states that FDA is to inspect domestic drug manufacturing establishments at least once every 2 years. Data show, however, that the number of registered human drug establishments has increased in the last 25 years while the number of FDA human drug inspections has decreased over the same period. The Agency no longer has the resources to meet this statutory requirement. Beginning in fiscal year 2005, as part of the Agency’s CGMPs for the 21st Century Initiative, the FDA will pilot a risk-based inspection model for prioritizing drug manufacturing establishments for routine inspection. The model is based on a risk-ranking and filtering method that is well-recognized, objective, and rigorously systematic. The study found that a risk-based approach toward selecting facilities for inspection should help the Agency make the best use of its limited surveillance and enforcement resources while maximizing the impact of those resources on the public health. In addition, the study found that lessons learned from the results of the 2005 pilot will be incorporated into future iterations of the risk-based inspection model.

PIC ID: 8083; Agency Sponsor: FDA-CDER, Center for Drug Evaluation and Research; Federal Contact: Wang, Brenda, 301-827-5266; Performer: FDA, Center for Drug Evaluation and Research, Rockville, MD

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