The FDA has been writing up companies on data integrity since the year 2000. Even after all the horror stories, and even after billions of dollars of market cap have been erased from it, here we are in 2017, still talking about it.

Here is some troubling text from recent Warning Letters that cite data integrity:

“…our investigator observed your warehouse supervisor tearing out pages from your firm’s annual report and placing the pages into his pocket.”

“Your Deputy Manager, Quality Control stated that it is common practice to ‘play with parameters’ to get the proper integration.”

“Your quality assurance unit provides analysts with blank controlled document forms that have already been approved and signed.”

“Investigators observed torn, partially complete QA-signed calibration records in the trash and observed QA staff shredding documents without recording the identity or the reason for shredding the documents.”

More to the point, this sums it up:

“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”

Again, just stop and think about this for a second. The drugs that we consume (80% of the active pharmaceutical ingredients that Americans consume is manufactured overseas) may be manufactured at a facility with these types of blatant problems.

And before we just pin these problems overseas, our recent analysis of 2016 Warning Letters show that 80% of GMP-related Warning Letters issued to US-based companies included a data integrity deficiency. It’s not just a China/India problem, it is worldwide.  While the US deficiencies are not as dramatic, the problem remains. See the infographic below.

As data integrity remains an area of focus for the FDA, Barbara Unger has analyzed this issue and written extensively about it. Get up to speed here:

  1. Data Integrity Whitepaper Believe it or not, it goes back to the 1980s.
  2. Data Integrity – The Whole Story It officially started with a warning letter in 2000.
  3. 2016 was the year the FDA exploded on China (largely because of data integrity)
  4. Comparison of EMA & FDA Guidance on Data Integrity There are some subtle differences, but both entities seem to have similar expectations.
  5. 2016 Warning Letters on Data Governance and Data Integrity It’s a growing list.

To go back to the original question. The FDA will move on from data integrity when the industry sufficiently addresses it. Not just the symptoms, but the root causes, many of which are structural/cultural and much more difficult to address. Also, the solutions are typically not an easy SOP change, but involves new equipment/software, training, and implementation. At that point, we’ll stop seeing data integrity in warning letters.

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