The Importance of GCP and GMP Audits to Verify Clinical Trial Compliance

Auditing is an essential element and key function within clinical trials, helping companies ensure patient and product safety, avoid gaps in compliance and prepare for regulatory inspections. In this white paper, we examine the key steps in audit performance – planning, preparation, conduct, reporting, follow-up, and closure – outlining the differences and similarities in process and scope of review between GCP and GMP-focused audits.