What is the time cycle for these audits? Is the audit a surprise?
USP will visit a site for approximately 3-5 days for the initial audit with 3 days being the target. The participant will have already prepared for the audit by completing pre-audit steps with USP. USP and the participant will collaborate on an audit date window, during which the participant will be manufacturing the ingredient. USP will inform the participant of the schedule and agenda for the audit. However, if USP has reason to be concerned about a situation or an event at the participant’s manufacturing facility, USP reserves the right to conduct an unannounced audit at its sole discretion.
