BioPharm International - March 2021

BioPharm International - Regulatory Sourcebook - March 2021

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4 BioPharm International eBook March 2021 Can FDA Reinvent On-Site Inspections? A plant inspection backlog, caused by COVID-19 restrictions, threatens innovation and public health. Now pressured to ramp up inspections, will FDA embrace new methods? O ver the past few decades, FDA has made significant progress in improv- ing its drug facility inspections pro- grams. Prev iously, FDA inspectors received little training and did not specialize along food or pharmaceutical lines. In a typical week, an inspector might examine a flour mill one day, a fish processing plant the next, a pharmacy's illegal drug sales the next, and then a pharmaceutical manufacturing facility (1). In the early 2000s, FDA began to elevate the inspection function, recognizing its strategic importance, and synchronizing inspec- tors' efforts more closely with those of new drug reviewers. FDA hired more and better-educated inspec- tors and trained them in modern quality methods, harmonized requirements with those of other regula- tory authorities, and formed closer ties with inspectors throughout the world, through the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Using risk- based methods to prioritize areas of focus, the agency increased the number of inspections, domestically and around the world. Then came the COVID-19 pan- demic, which, in March 2020 pushed the agency to halt all routine on-site pre-approval and surveillance inspections. Where FDA had inspected 116 biologics facilities in 2019, its inspectors only examined 28 such facilities in 2020 Pharmaceutical facility inspections plummeted from 779 in 2019 to 116 in 2020 (2). Kzenon - AGNES SHANLEY Regulatory Sourcebook Quality

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