Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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4 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 P h a r mTe c h . c o m Quality O ver the past few decades, FDA has made significant prog- ress in improving its drug facility inspections programs. Previously, 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 inspectors' efforts more closely with those of new drug application reviewers. FDA hired more and better- educated inspectors and trained them in modern quality methods, har- monized requirements other regulatory 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 inspec- tions domestically and around the world. Then came the COVID-19 pandemic, which, in March 2020 pushed the agency to halt all routine on-site pre-approval and surveillance inspections. Where FDA had in- spected 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). Interim measures seen as inadequate Once it suspended routine inspections, FDA took steps to ensure that it could still supervise operations without sending inspectors onsite such as the review of documents, or accepting recent notes from inspections performed by some PIC/S member agencies. However, the United States Government Accountability Office (GAO) and Can FDA Reinvent On-Site Inspections? Agnes Shanley A plant inspection backlog, caused by COVID-19 restrictions, threatens innovation and public health. Now pressured to ramp up inspections, will the agency embrace new methods? KZENON - STOCK.ADOBE.COM

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