ARTICLES BY BARBARA UNGER

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

  • What Risk Factors Does The FDA Consider In Scheduling Drug GMP Inspections?
    What Risk Factors Does The FDA Consider 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
    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
    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.

  • FY2017 FDA Drug Inspection Observations And Trends
    FY2017 FDA Drug Inspection Observations And Trends

    This article presents the most recent publication of GMP drug product inspection data from the FDA's Center for Drug Evaluation and Research (CDER), which addresses drug inspections conducted in FY2017. It looks at five years of data from the FDA, examines data from 2017, and evaluates five years’ worth of trends in GMP inspection enforcement.

  • What’s New In MHRA’s Revised Data Integrity Guidance — A Detailed Analysis
    What’s New In MHRA’s Revised Data Integrity Guidance — A Detailed Analysis

    The Medicines and Healthcare Products Regulatory Agency (MHRA) published a revision to its 2015 Data Integrity Guidance, finalizing the draft revision published for consultation in 2016. The revision was a coordinated effort among the GCP, GDP, GLP, GMP, and GPvP inspection groups, reflecting a broad source of input.

  • CDER’s FY2017 Enforcement Activity — What Can We Learn?
    CDER’s FY2017 Enforcement Activity — What Can We Learn?

    The FDA recently published its enforcement statistics for FY2017, a practice it started with the publication of FY2009 data. The metrics provide a high-level overview of enforcement actions including injunctions, seizures, warning letters, and recalls conducted by all FDA centers. This article will look at the data from the enforcement metrics in two ways.

  • An Analysis Of FDA FY2017 Drug GMP Warning Letters
    An Analysis Of FDA FY2017 Drug GMP Warning Letters

    FY2017 saw another year of increase in the number of drug GMP warning letters issued by the FDA, though not as dramatic a difference as between FY2015 and FY2016. This article presents a detailed summary of those warning letters, as well as a comparison of trends since fiscal year 2013.

  • Best Practices For Data Integrity Oversight At Your Contract Manufacturer
    Best Practices For Data Integrity Oversight At Your Contract Manufacturer

    Part 1 of this two-part article addressed FDA warning letter enforcement actions and discussed things that can go awry in these relationships related to data governance and data integrity. In Part 2, we turn our attention to health authority GMP guidance on contractual relationships and best practices that should be considered in this area.

  • Data Integrity & Your Contract Manufacturer — Common Pitfalls To Avoid
    Data Integrity & Your Contract Manufacturer — Common Pitfalls To Avoid

    This two-part article will address how sponsors can effectively ensure confidence in data integrity at their contract development and manufacturing organizations (CDMOs) and have confidence in the information upon which they base lot release decisions.

  • An Analysis Of FDA Warning Letters On Data Governance & Data Integrity
    An Analysis Of FDA Warning Letters On Data Governance & Data Integrity

    Failures in data governance and data integrity have been more prominent in health authority enforcement actions in the past few years. Health authorities review thousands of pages of data in original submissions and supplements covering the broad GxP area. Inspectors then review manufacturing and test data on-site during pre-approval inspections and routine GMP inspections.

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

Barbara Unger

Barbara Unger

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Barbara Unger formed Unger Consulting, Inc. in December 2014 to provide GMP auditing and regulatory intelligence services to the pharmaceutical industry. She has extensive expertise in this area having developed, implemented, and maintained the GMP regulatory intelligence program for eight years at Amgen Inc. This included surveillance, analysis, and communication of GMP related legislation, regulations, guidance, and industry compliance enforcement trends. Barbara was the first chairperson of the Rx-360 Monitoring and Reporting work group (2009 to 2014) that summarized and published relevant GMP and supply chain related laws, regulations, and guidance. She also served as the chairperson of the Midwest Discussion Group GMP-Intelligence sub-group from 2010 to 2014.


  Before Amgen, Barbara worked for the consulting firm Don Hill and Associates, providing regulatory and quality services to the pharmaceutical industry, and for Eli Lilly and Company in quality and CMC regulatory affairs positions. She began her career in the pharmaceutical / device industry with Hybritech Inc. and received a bachelor's degree in chemistry from the University of Illinois in Urbana Illinois.