Pre-Approval Inspections (PAIs)
A. The manufacturing facility is inspected by the FDA after an NDA, abbreviated antibiotic drug application (AADA), or ANDA is submitted and before the application is approved.
B. A PAI may also be initiated if a major change is reported in a supplemental application to an NDA, AADA, or ANDA.
C. During the PAI, the FDA investigator:
- performs a general current good manufacturing practice (cGMP) inspection relating specifically to the drug product intended for the market;
- reviews the development report to verify that the drug product has enough supporting documentation to ensure a validated product and a rationale for the manufacturing directions;
- consults the chemistry, manufacturing, and control (CMC) section of the NDA, AADA, or ANDA and determines the capability of the manufacturer to produce the drug product as described;
- verifies the traceability of the information submitted in the CMC section to the original laboratory notebooks, electronic information, and batch records;
- verifies and ensures that all the quality systems are in place to manufacture the product so it retains the identity, strength, quality, and purity of the drug product that were approved by the center; and
- recommends approval for the manufacture of the drug product based on the status of the inspection.
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