Manufacturing Assessment and Pre-approval
OC oversees the pre-approval program in terms of establishment evaluations. When establishments are named in new drug applications (NDAs) and generic drug applications (ANDAs), the names and contact information are sent to OC; then OC evaluates and forwards the information to ORA.
OC serves as a communication hub between CDER review divisions and ORA field offices. It sends domestic field investigators requests to conduct inspections and submits recommendations as to whether or not the establishments qualify to be named in an application.
OC conducts the initial cGMP evaluations of establishments to determine if the application or product submitted meets product specific criteria. The compliance program guidance manual (CPGM) provides a frame of reference when determining if a firm should be inspected before an application is approved, and makes sure that the establishment is adhering to good manufacturing practices. The evaluation is sent to the appropriate FDA district field office for review and recommendation. Once OC has the district's recommendation, an overall recommendation is made.