Barbara Unger

ARTICLES BY BARBARA UNGER

• 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. 

• What Can We Learn From 2016 FDA & MHRA Drug GMP Inspection Observations?

  This article presents the most recent GMP inspection data from CDER and MHRA (Medicines and Healthcare Products Regulatory Agency).  The CDER data and the MHRA data come from GMP inspections conducted in 2016.

• Is GMP Quality System Auditing Fundamentally Flawed? A Data Integrity Alternative

  Pharmaceutical inspection approaches rely on the evaluation of several or all components of the quality system: quality, production, laboratory, materials, facilities and equipment, and packaging and labeling.  One area where it has serious limitations, however, is in the assessment of data management and data integrity.

• An Analysis Of FDA FY2016 Drug GMP Warning Letters

  This article presents a detailed summary of the drug GMP warning letters issued by FDA in FY2016, as well as a comparison of trends in this area since FY2013. Monitoring publicly available enforcement actions and trends as part of a comprehensive GMP intelligence program is crucial, because FDA expects firms to monitor these actions and correct similar deficiencies at their site(s).

• Comparing Recent Data Management/Integrity Guidances From MHRA, WHO, & PIC/S

  Over the past two years, several major regulatory authorities have published new guidance documents addressing data management and data integrity in the pharmaceutical industry.

• Comparing Recent Data Management/Integrity Guidances: FDA, EMA, & China FDA

  In 2015 and 2016, six major international regulatory authorities published guidance documents addressing data management and data integrity. Two of the guidances — the draft guidance published by the U.S. Food and Drug Administration (FDA) in April 2016 and the guidance posted by the European Medicines Agency (EMA) in August 2016, take a question and answer approach.

• What Recent FDA Enforcement Actions In The EU Mean For FDA/EMA Cooperation

  FDA and the EU have taken serious enforcement actions against firms in the other’s geographic jurisdiction during the calendar year 2016. In the preceding article, we looked at European inspectorate actions against sites in the U.S. Issues identified as problematic included deficiencies in aseptic processing of parenteral drugs, data integrity concerns, lack of controls to prevent cross-contamination, and failure to adequately address observations from previous inspections. FDA had inspected each of the three facilities within the past year.