ARTICLES BY BARBARA UNGER
FDA Releases Guidance On Normal GMP Operations During COVID-19
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
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?
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 Communications
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 Manufacturers
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 Report
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.
The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter
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.
An Analysis Of MHRA’s Annual GMP Inspection Deficiencies Report
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.
UPDATED: New EMA Requirements On Nitrosamines — What ALL Pharma Companies Need To Know
The EMA recently issued two new publications containing information on nitrosamines for marketing authorisation holders (MAHs). Every MAH and manufacturer of chemically synthesized APIs and resulting drug products should carefully read the new EMA expectations on potential nitrosamine contamination.
FDA FY2019 Drug Inspection Observations And Trends
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.