If the repackager or relabeler is a contractor, it becomes an extension of the manufacturer. The
manufacturer is still responsible for assuring compliance of GMPs of that contractor for whatever
activities they have contracted out. If you have a contract lab or a contract micronizer, it is still
your responsibility to assure that your contract micronizer or lab, or repackager or relabeler is
operating within compliance for GMPs for those activities that they are performing. If they’re
referenced in a drug application, a regulatory agency also may do an audit or inspection of those
contracted activities. If it’s a contractor, it’s quite clear who has the responsibility; it’s still your
responsibility as the manufacturer.
