ARTICLES BY BARBARA UNGER

• Top 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter In 2019

  1/18/2021

  In Part 1 of this two-part article, we evaluated the U.K. Medicines and Healthcare products Regulatory Agency’s GMP inspection data for 2019 and addressed the critical and major deficiencies. In this part, we take the 10 chapters and annexes with the highest numbers of deficiencies and do a deeper dive into the specifics of each.

• An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

  1/11/2021

  The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) recently published its GMP deficiencies data for drug product issued during inspections in 2019. This article provides a high-level overview of that data, including trends from the four most recent MHRA reports (2015, 2016, 2018, and 2019), and identifies and evaluates the critical and major deficiencies from 2019. 

• FDA FY2020 Drug Inspection Observations And Trends

  12/9/2020

  This article presents the FDA's most recent publication of GMP drug inspection data, which address drug inspections conducted in FY2020. We examine data from FY2020 and evaluate five years' worth of trends in drug GMP inspection enforcement.

• FDA Releases New Guidance On Resuming Normal GMP Operations During COVID-19

  9/18/2020

  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.

• Unpacking FDA’s New Guidance On Controlling Nitrosamine Impurities In Drugs

  9/10/2020

  On Sept. 2, 2020, the Federal Register announced the availability of a final FDA guidance, "Control of Nitrosamine Impurities in Human Drugs." This guidance is immediately effective and was not subject to the usual comment period “…because of the importance of providing timely information to manufacturers regarding risk assessments, testing, and other appropriate actions they should take."

• EMA Publishes 3 Noteworthy Updates Amidst Avalanche Of COVID-19 Communications

  4/3/2020

  While communications from health authorities continue to pour in regarding actions they are taking to mitigate the impact of the COVID-19 pandemic, the EMA published three new items that merit attention from the life sciences industry. Two of them result from the pandemic; the third has been under development.

• FDA FY2019 Warning Letter Trends: A Closer Look At Drug Product Manufacturers

  2/28/2020

  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.
   

• U.S. Sites Play Surprise Starring Role In FDA’s Drug GMP Warning Letter Report

  2/21/2020

  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.

• FDA FY2019 Human Tissue And Cell Therapy Observations And Trends

  1/9/2020

  Very soon after publication of the FY2018 data on human tissue and cell therapy products, the FDA released the data from FY2019, which we address here. We examine data from FY2019 and a total of five years’ worth of trends in GMP inspection enforcement in this area. The regulations that govern this area, 21 CFR 1271, are the same regulations that govern segments of human cell therapy and gene therapy products. Human cell and gene therapy products are part of FDA’s Regenerative Medicine framework.

• FDA FY2019 Drug Inspection Observations And Trends

  12/6/2019

  This article presents the most recent publication of GMP drug inspection data from CDER, published November 15, 2019 and addressing drug inspections conducted in FY2019. We'll also take a look at seven years’ worth of trends in drug GMP inspections.

• FDA FY2018 Human Tissue And Cell Therapy Observations And Trends

  10/24/2019

  This article presents the most recent publication of GMP Human Tissue for Transplantation Form 483 observation data from the FDA. We examine data from FY2018 and evaluate a total of four years’ worth of trends in GMP inspection enforcement in this area.

• FDA FY2018 Drug Inspection Observations And Trends

  10/7/2019

  The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency's 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.

• An Analysis Of 2018 FDA Warning Letters Citing Data Integrity Failures

  6/12/2019

  FDA enforcement for failures in data integrity and data governance began almost 20 years ago, and these areas remain as enforcement initiatives of the FDA and other global health authorities to this day.

• FDA’s First DSCSA Warning Letter — A Closer Look

  3/11/2019

  The FDA issued the first warning letter related to the DSCSA amendments to the FD&C Act. This article takes a look at this warning letter and explains why pharma manufacturers should care.

• An Analysis Of FDA FY2018 Drug GMP Warning Letters

  2/1/2019

  This article presents a detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements. This allows manufacturers and sponsors to identify new trends in the focus of FDA inspectors and to act to address or justify similar situations at their own firms.