What is the remedy structure of the USP Audit when a deficiency is identified?
Deficiencies noted during the audit will be described in writing in the form of a report and grouped by their severity. Manufacturers are required to address each deficiency with the goal of full compliance to the ICH Q7 Good Manufacturing Practices Guide. All deficiencies must be fully addressed before the verification process may move to the next program step. Details on types of deficiencies can be viewed in the program’s participants manual (2MB).
