FDA Answers Data Integrity Questions

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New FDA guidance developed to identify lapses in data integrity and promote best practices.

With data integrity identified as a primary focus of its enforcement actions, FDA issued a new guidance document on Dec. 12, 2018, to provide definitions and the agency’s current thinking on best practices. The guidance, Data Integrity and Compliance with Drug cGMP: Questions and Answers, outlines the design, operation, and monitoring of data integrity systems.

In a statement accompanying the release of the document, the agency noted that the revised recommendations were developed to help manufacturers address “identified data integrity lapses, implement best practices to address gaps that can create risks to data integrity, and ensure consistent awareness and commitment to ensuring data integrity.”

In addition to definitions of system components, the guidance answers common questions including the following:


  • When is it permissible to invalidate a cGMP result and exclude it from the determination of batch conformance?

  • How should access to cGMP computer systems be restricted?

  • Who should review audit trails?

  • Can electronic signatures be used instead of handwritten signatures for master production and control records?

“We continue to observe cGMP violations involving data integrity, which underscore the need to provide industry with guidance and address observed problems. When we see these violations, we take appropriate enforcement actions against manufacturers,” wrote Gottlieb in the statement. “We also expect all manufacturers to conduct timely and appropriate investigations of suspected problems, including expanding the scope beyond the narrow problem first observed into any other potentially impacted data, batches, or products. Pharmaceutical quality can only be assured by robust quality control, which includes vigilant oversight of data integrity.”

Sources: FDA Guidance and FDA Statement