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USFDA Compliance Program: Preapproval Inspections (PAIs) for Drug Manufacturing Facilities
Before approving a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), the U.S. Food and Drug Administration (FDA) must ensure that the manufacturing facilities are capable of consistently producing medicines that meet Current Good Manufacturing Practice (CGMP) requirements. Preapproval Inspections (PAIs) are conducted to evaluate manufacturing readiness, verify the accuracy of Chemistry, Manufacturing and Controls (CMC) information, and confirm that facili
Sharan Murugan
2 days ago3 min read