Continued from Part 1 and Part 2


Data integrity and data governance remain an initiative of global health authorities:

  • The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) was the earliest to enter the area in 2015 with their guidance and a published draft revision in 2016.
  • European Medicines Agency (EMA), World Health Organization (WHO), Pharmaceutical Inspection Co-operation Scheme (PIC/S), Australia, Canada, and China followed in 2016.
  • Further, this is not limited to the GMP area but now includes GCP, with the most impactful cases at sites that perform bioavailability and bioequivalence studies.
    • For these firms, the data for hundreds of products are now questionable. Sponsors must frequently repeat the studies at a different site.
    • Most recently, this has included failures identified at GVK and Semler Research.
    • Consequences at Semler included a 3-page form 483, untitled letter, WHO notice of concern, and EMA recommendation of suspension.

GMP enforcement citing data governance and data integrity has not diminished — expanding both the number of warning letters and their geographic distribution. However, while the number of warning letters has increased markedly over the past 3 years, the percentage has decreased slightly.

In CY2017 an increasing number of countries were home to sites that were the subject of these warning letters. Deficiencies in the area of data governance and data integrity have remained markedly consistent over the 10 years addressed in this report, with a few new areas identified each year. This year saw the addition of 3 new focus areas including:

  • Firms that repackage APIs were transferring analytical results onto a Certificate of Analysis on their letterhead — making it appear that they generated the results. Inadequate labeling obscures the supply chain from the company that purchases and uses the material in the manufacturing of drug products.
  • FDA cited firms for an apparently excessive number of aborted analytical runs.
  • FDA cited firms for manipulation of “integration suppression” within chromatography data systems intending to obscure or minimize impurity peaks.

These 3 areas merit our attention as we progress through 2018. I watch for:

  • This type of problem to expand in scope to more OTC manufacturers because actions in this area is a clear trend that began in 2017.
  • And for this topic to be cited more frequently in enforcement actions taken against compounding pharmacies and outsourcing facilities.
  • Previously, most of the problems in this area addressed failures in aseptic processing (including facilities and equipment issues). Thus, I look for data integrity to be cited more frequently in both forms 483 and warning letters issued to these firms.

About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence.  She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry.  At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers.  She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc.  This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends.  This was an essential service and tool within the Corporate Audit function.

Unger Consulting Inc. | | 805.217.9360

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