BioPharm International - March2020

BioPharm International - Regulatory

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4 BioPharm International eBook March 2020 Is There a "New Normal" for Drug Quality? With some FDA inspections on hold, will the US drug supply maintain its quality standards? I n a February 2020 report (1), FDA's Office of Pha r maceut ica l Q ua lit y (OPQ ) noted t hat, "Quite simply, the quality of our drug supply is better than ever before." OPQ , which was launched in 2015 to oversee quality standards for all innovator and generic dr ugs marketed in the United States, noted a number of achievements in 2019, including 357 inspections for application approval and nearly 200 quality assessments of appli- cations expedited by OPQ to avert potential drug shortages for patients. Public perceptions about drug quality can be off tar- get from reality. A 2019 survey conducted by FDA and WebMD found that nearly one-quarter of physicians surveyed believed an advertisement for a drug was an indicator of quality. However, nearly half of the physi- cians responding to that survey said drugs manufactured abroad were of lower quality than those manufactured in the United States. That assessment is troubling, in light of the number of APIs that are manufactured offshore and disruptions to quality oversight efforts. WARNING LETTERS REPORT FAMILIAR VIOLATIONS Through early March 2020, FDA reported eight drug recalls, including four related to nitrosodimethyl- amine impurities (2), an ongoing concern traced to quality problems with the manufacture and testing of APIs manufactured overseas. On the compliance front, FDA's Center for Drug Evaluation and Research—through mid-March 2020— issued 12 warning letters to facilities in China, India, tomertu - RITA PETERS Regulatory Sourcebook Regulatory Update

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