I am trying to determine if audits are required for non-GMP clinical sites in the USA that will perform encapsulation of a non-sterile, solid drug substance for a Phase 1 drug drug interaction study. I would consider this compounding but this site is not an FDA 503B approved site.
In your experience is this required for these clinical sites that do encapsulation work in the pharmacy? If you have not audited these sites, what kind of rationale would you provide to justify not auditing them?
Thank you in advance!