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Data Integrity Code of Conduct

While the FDA asks pharma companies to heed its warnings around good manufacturing practices, the Parenteral Drug Association outlines actions to take.

Els Poff, Executive Director of the Data Integrity Center of Excellence at Merck
Els Poff, Executive Director of the Data Integrity Center of Excellence at Merck

Data is the great enabler when it comes to manufacturing processes. But not all data is good. Industry pundits estimate that about 85 percent of the data generated in manufacturing has absolutely no value at all. Which makes one wonder if some of that useless information can cause problems.

What to do with all that data—the good and the bad— is not a new area of discussion, but it is still on the forefront of the minds of pharmaceutical executives, especially as they respond to Food & Drug Administration (FDA) enforcement actions. In recent years, there has been an increase in warning letters to companies around deviations from current good manufacturing practices (CGMP) in manufacturing facilities.

The number of drug GMP warning letters went from 42 in 2015 to 102 in 2016 to 114 in 2017. This puts more emphasis on data integrity in the industry.

The FDA uses the acronym ALCOA to define data integrity, meaning, it is attributable (who did it/source data), legible (recorded in a permanent medium and it is readable), contemporaneous (data recorded in real time), original (an original or certified true copy of data), and accurate (no errors or editing performed without documented amendments).

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