ARTICLES BY BARBARA UNGER
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.
FDA FY2018 Drug Inspection Observations And Trends
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
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
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
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.
FDA’s New Data Integrity Guidance — Highlights & Observations
The FDA recently posted the final guidance Data Integrity and Compliance with Drug CGMP Questions and Answers, finalizing a draft first published in April 2016. This article provides an overview and analysis of the guidance's 18 questions, which span the broad areas of data integrity and data governance.
FDA Considers These Risk Factors In Scheduling Drug GMP Inspections
The globalization of the supply chain has expanded the scope of sites the FDA must routinely inspect from those in the U.S. to facilities worldwide.
Analyzing 2017 FDA Warning Letters Citing Process Validation, Supplier Controls, & OTC Manufacture
Shortcomings in data governance/data integrity and are a prominent feature in drug GMP warning letters over the past three years. FDA inspections also focused on contracted services. Additional areas were the subject of FDA investigator attention in CY2017 but may have been overshadowed by these two. This article explores several of those other areas.
An Analysis Of 2017 FDA Warning Letters On Data Integrity
Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. While the FDA is not the only health authority that identifies these issues in inspections and enforcement actions, its transparency ensures the data is available.