This has to do with inspection of packaging and labeling facilities for APIs. Is this intended to be the same level as for drug product line clearance? Can production personnel carry out this check, and does the requirement apply to API only or also to isolated intermediates?
The intent of the EWG here was to assure that the procedures exist to prevent the mislabeling or
mix-up in the labeling. Any organizational unit can actually conduct it. You have that flexibility.
