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FDA keeps spotlight on GMP data integrity

  • The Food and Drug Administration on Thursday issued a reminder to drug manufacturers that data integrity remains high on the regulator’s agenda of Good Manufacturing Practice-related concerns, publishing new guidance aimed at helping drugmakers meet its standards.
  • The document, which updates a 2016 version, lays out a series of questions and answers for drugmakers explaining how companies can ensure manufacturing data sets are complete, consistent and accurate. While a technical concern, the FDA makes clear that data errors carry real risk to patient health.
  • Guidance isn’t the only lever the FDA can pull to help companies comply. In recent years, the agency has flagged data integrity issues in numerous warning letters following inspections and pre-approval assessments.

At its most basic, data integrity centers on maintaining complete, consistent and accurate data that’s attributable and contemporaneously recorded.
Lapses, however, are common — particularly among foreign drugmakers — and these failures can mask broader quality control issues. Among many violations, some of the most common involve oversights like sharing log-ins or improperly editing logged data.
Sometimes these missteps are the result of deceptive practices, FDA Commissioner Scott Gottlieb noted in a statement, but usually they stem from inadequate processes and systems.
“In all cases, we regard any lapse in data integrity as a risk to patient safety. Patients can’t be assured of the safety and effectiveness of their medication when data has been altered,” Gottlieb said.
The FDA frequently notes data integrity issues on its Form 483s, which are issued following a manufacturing site inspection. These can lead to warning letters or import alerts, depending on the seriousness of the violations. The FDA also has the power to withhold approval of new applications listing an incompliant company as a manufacturer.
In recent examples, Surmasis Pharmaceutical and Hanlim Pharm both received warning letters from the FDA on data integrity.
Slip-ups can carry greater weight, too. Earlier this year, data integrity failings lost Akorn a takeover deal — a Delaware judge allowed Fresenius Kabi to pull out of the $4.3 billion deal to buy up Akorn following investigations into Akorn’s data quality and integrity, as well as its product development.
Along with developing fresh guidance for industry, the FDA also noted it is working with foreign regulators to help police facilities around the world.