FDA Collates GMP Data Integrity Advice Into Draft Guidance

A draft guidance in Q&A-format could help stave off missteps flagged in recent warning letters, more of which focus on data integrity. One basic piece of advice: data generated to satisfy a CGMP requirement is a CGMP record that must be retained.

Questions and answers about data integrity FDA published April 14 as draft guidance could go a long way toward helping drug manufacturers avoid the type of import alerts and warning letters that in recent years have dominated the agency's drug good manufacturing practices enforcement activities.

The percentage of firms placed on drug GMP import alert that have data integrity issues steadily has risen from zero...

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