ARTICLES BY BARBARA UNGER
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FDA Releases Guidance On Normal GMP Operations During COVID-199/18/2020
Most FDA guidance on COVID has been associated with tools to combat the pandemic. This new guidance should be read by all drug and biologic manufacturers, whether or not they produce COVID-related products.
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FDA FY2019 Warning Letters: A Closer Look At Drug Manufacturers2/28/2020
Part two of this series takes a deep dive into the types of drug manufacturers that received warning letters and their locations, including data on how frequently the FDA recommends that firms hire qualified consultants and its request for “independent assessments” in warning letters.
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U.S. Sites Play Surprise Role In FDA's Drug GMP Warning Letter Report2/21/2020
Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.
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The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter1/31/2020
This is the second article in a two-part series reviewing the MHRA’s publication of the GMP deficiencies for drug product published in October 2019. Part 1 identified and evaluated the critical and major deficiencies. Part 2 presents the 10 most frequently cited paragraphs for the 10 chapters and annexes with the most frequently cited deficiencies.
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An Analysis Of MHRA's Annual GMP Inspection Deficiencies Report1/27/2020
To publish the GMP deficiencies for drug product issued during its 2018 inspections, MHRA released a 6,200+ line Excel spreadsheet in October 2019. Here, Barb Unger distilled that data into easily-digestible prose, to save you the spreadsheet struggle.