Ensuring cGMP Compliance and Quality Standards for Controlled Substances

March 15, 2023 2:15pm

Francis Godwin
Director, Office of Manufacturing Quality
U.S. Food and Drug Administration

Marian J. Lee
Partner
Gibson, Dunn & Crutcher LLP

Lowell Zeta
Partner
Hogan Lovells US LLP

  • Reviewing current Good Manufacturing Practice regulations relative to controlled substances
    • Ensuring product integrity through product and facility registration; inspections; chain-of-custody documentation; and technologies to protect against counterfeit, diverted, subpotent, adulterated, misbranded, and expired drugs.
      • Knowing the standards for active pharmaceutical ingredients
    • Learning the unique considerations for contract manufacturing
  • Reviewing the current Chemistry, Manufacturing and Controls regulations
    • Synchronizing CMC and GMP
    • Considering the draft Quality System Regulation and OMB’s review