ARTICLES BY BARBARA UNGER
Do These Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus?2/10/2021
The FDA posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters represent a renewed emphasis on both alternatives to on-site inspections and the importance of purchasing controls and supplier management.
10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter1/18/2021
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 Report1/11/2021
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 Trends12/9/2020
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 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.
Unpacking FDA’s New Guidance On Controlling Nitrosamine Impurities In Drugs9/10/2020
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."
Nitrosamine Impurities In Medicines: What Have We Learned?7/8/2020
This article discusses the new EMA report "Lessons Learnt from Presence of N-nitrosamine Impurities in Sartan Medicines," sharing recommendations and the path forward suggested by the European regulators, as well as lessons learned from the GMP sampling, testing, and inspection processes.
EMA Publishes 3 Noteworthy Updates Amidst Avalanche Of COVID-19 Communications4/3/2020
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 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.
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.