FDA Releases New Data Integrity Guidance to Improve Drug Quality

Samara Rosenfeld
DECEMBER 12, 2018
fda data,data integrity,pharmaceutical data
The FDA released a new guidance focused on data integrity.

Today the U.S. Food and Drug Administration (FDA) announced an increased focus on data integrity to improve drug quality.

FDA Commissioner Scott Gottlieb, M.D., said the regulator is releasing new guidance, with the goal to ensure that data associated with drug manufacturing are complete, consistent and accurate to ensure reliability.

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There have been times when drug quality data and information were not accurate, due to inadequate processes and systems to ensure reliable and accurate data, Gottlieb added. With altered data, patients can’t be assured of the safety and effectiveness of their medication.

The FDA wants to build on old policies that focused on efforts to prevent, uncover and combat data integrity lapses by updating their guidance for industry on promoting data integrity and compliance with current good manufacturing practices.

According to the announcement, one of the most critical ways to guarantee quality is to prevent data integrity lapses in the first place. The FDA has worked to provide clear guidance, so manufacturers have the tools and systems to prevent inferior products from entering the marketplace.

“A work environment where employees are encouraged to promptly identify and properly report data issues is essential to product safety,” Gottlieb wrote.

Per the guidance, firms should implement meaningful and effective strategies to manage their data integrity risks based on their understanding and knowledge management of technologies and business models. The FDA recommends training personnel to prevent and detect data integrity issues.

If a data integrity problem occurs, the FDA suggests remedying the problem by determining the cause and the risk of its effects and then implementing a management strategy that includes a global corrective action plan.

The FDA will also use inspections to uncover data integrity problems by using its pre-approval inspections process, in addition to conducting thorough assessments of applications prior to approval and when companies submit information about changes to their manufacturing.
 
Additionally, expanding the agency’s partnerships with international regulatory counterparts will allow the FDA to exchange information about quality and data integrity violations that are observed in facilities globally.

The new guidance, Data Integrity and Compliance with Drug CGMP: Questions and Answers, is an update on a 2016 draft that covers the design, operation and monitoring of systems and controls to maintain data integrity.

“The revised recommendations are aimed at helping 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,” Gottlieb noted.

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