regulatory
US FDA updates data-integrity expectations for API manufacturers
A refreshed guidance restates ALCOA+ record-keeping requirements and clarifies audit-trail review during routine inspections of active-ingredient facilities.
The guidance does not introduce new obligations but consolidates expectations that inspectors have applied inconsistently. Manufacturers should confirm that electronic batch records capture a complete, attributable and contemporaneous audit trail.
For suppliers listing on PharmaLink, a current data-integrity posture is increasingly a buyer pre-qualification criterion — several verified buyers now request audit-trail review evidence alongside the CoA.