FDA Guidance

BREAKING NEWS – FDA Releases Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry

 

BREAKING NEWS 

FDA Releases Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry

On December 12, 2018, The US Food and Drug Administration (FDA) 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.  Revisions 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.

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.

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.

Review and download a copy of the Guidance here.