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Revised risk model for inspections may include country of origin

This article was originally published in The Gold Sheet

Executive Summary

FDA may be revising its risk ranking model to include adding the country of origin as a factor in deciding which firms to inspect first, reported Edwin Rivera-Martinez, CDER branch chief for manufacturing assessment and pre-approval compliance, at the recent GMP by the Sea Conference in Cambridge, Md. The agency totals up a risk score in three areas to determine the firm's chances for being inspected: the facility score, the product score, and the process score. The higher the total score, the greater the chances the site will be chosen for inspection. FDA uses the model to prioritize its routine surveillance inspection program for domestic and foreign sites in light of the dramatic decline in agency resources available for inspections in recent years. "This model is still evolving and drives about half of our inspections," he said. "One of the things we are considering as another risk factor is whether or not we should have a risk category for a country where we know from our experience that we have, say, an underdeveloped regulatory body and perhaps we should incorporate this risk factor into our model," reported Rivera. The facility score looks at the size of the facility, the type of establishment such as whether the firm is a drug manufacturer or a contract sterilizer, the results of the last three inspections, and the firm's field alert history. The product score looks at whether the drug is a prescription drug or an OTC drug, the drug's therapeutic category, and whether the drug is sterile or non-sterile. The process score evaluates the ability of the firm to maintain the manufacturing process in the state of control and the potential for contamination



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