Articles by Barbara Unger

  1. Analyzing 2017 FDA Warning Letters Citing Process Validation, Supplier Controls, & OTC Manufacture 6/18/2018

    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.

  2. An Analysis Of 2017 FDA Warning Letters On Data Integrity 5/18/2018

    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.

  3. FY2017 FDA Drug Inspection Observations And Trends 4/18/2018

    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.

  4. What's New In MHRA's Revised Data Integrity Guidance — A Detailed Analysis 3/19/2018

    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.

  5. CDER's FY2017 Enforcement Activity — What Can We Learn? 2/26/2018

    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.

  6. An Analysis Of FDA FY2017 Drug GMP Warning Letters 1/10/2018

    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.

  7. Best Practices For Data Integrity Oversight At Your Contract Manufacturer 12/4/2017

    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.

  8. Data Integrity & Your Contract Manufacturer — Common Pitfalls To Avoid 11/3/2017

    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.

  9. An Analysis Of FDA Warning Letters On Data Governance & Data Integrity 7/14/2017

    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.

  10. What Can We Learn From 2016 FDA & MHRA Drug GMP Inspection Observations? 5/2/2017

    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.