Ensuring cGMP Compliance and Quality Standards for Controlled Substances
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