Data Integrity Q&A: FDA Finalizes Guidance

Regulatory NewsRegulatory News | 12 December 2018 |  By 

The US Food and Drug Administration (FDA) on Wednesday finalized its questions and answers guidance on complying with data integrity requirements under current good manufacturing practice (CGMP) for drugs and biologics.

The guidance updates a draft version released in 2016 and has been revised to include additional information on the agency’s current thinking on data integrity to help drugmakers identify lapses and implement best practices to shore up any gaps in their data integrity processes.

“FDA expects that all data be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks,” FDA writes.

FDA says the guidance was developed in response to an increase in data integrity violations observed during inspections that have resulted in warning letters, import alerts and consent decrees in recent years.

The guidance features 18 questions and answers relating to data integrity practices and lists the relevant sections of the regulations governing data integrity under 21 CFR parts 210, 211 and 212.

The questions themselves cover a range of topics including how access to CGMP computer systems should be restricted, how blank forms should be controlled and how often audit trails should be reviewed.

FDA also removed a section of the guidance that covered independent security role assignments for small operations because the issue is covered in another guidance, PET Drugs—Current Good manufacturing Practice (CGMP).

“Over the past decade, we’ve uncovered situations in which drug quality data and information are not accurate. This can mask problems and failures. Sometimes, data integrity concerns are a result of deceptive practices. But more commonly, they’re a result of inadequate processes and systems to ensure reliable and accurate data. In all cases, we regard any lapse in data integrity as a risk to patient safety,” said FDA Commissioner Scott Gottlieb.

Gottlieb also pointed to FDA’s partnerships with international regulators, such as the US-EU mutual recognition agreement on GMP inspections, as a means of boosting the agency’s reach when it comes to identifying data integrity violations.

“As the industry has globalized, we’ve expanded our partnerships with our international regulatory counterparts. This allows us to regularly exchange information about quality and data integrity related violations if they’re observed in facilities around the world,” Gottlieb said.

FDA, Federal Register Notice


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy