Preapproval Inspections

ARTICLES

Sampling - Preapproval

Investigators should not routinely collect samples during the pre-approval inspection. Read More

Conformance To Application - Preapproval

Verify that the formulation, manufacturing or processing methods, and analytical (or examination) methods are consistent with descriptions contained in the CMC section of the application for the biobatch (and other pivotal clinical batches, when applicable), the proposed commercial scale batch, and the API(s). Read More

Common Deficiencies - Preapproval

Districts are asked to either perform an inspection for a specific establishment named in a specific application or to provide a recommendation of site acceptability. At the conclusion of a pre-approval inspection, the district needs to make a recommendation to approve or withhold approval based on outcome of the establishment inspection. Read More

Readiness For Commercial Operation

Determine whether the establishment(s) has a quality system that is designed to achieve sufficient control over the facility and commercial manufacturing operations. Read More