Introduction to Drug Law and Regulation: Understanding How FDA Regulates the Drug Industry

Cathy Burgess presented "Regulation of Drug Manufacturing" and "When FDA Knocks: How to Handle a CGMP Inspection" during this conference sponsored by the Food and Drug Law Institute. The following topics were covered during the "Regulation of Drug Manufacturing" session.

• Establishment Registration and Drug Listing
• Adulteration
                  1. Current Good Manufacturing Practices (cGMPs)
                  2. Departure from Compendial or Represented Standards
                  3. Insanitary Conditions
•  Inspections
                  1. Inspection Process and Procedure
                  2. Search Warrants
                          a. Administrative
                          b. Criminal
                  3. Photographs and Recordings
                  4. Affidavits and Declaration
                  5. Types of Inspections
                          a. Routine
                          b. For Cause
                          c. Follow Up
                          d. Pre-Approval Inspection (PAI)
• Responding to 483 Observations – Closing an Inspection
                  1. Establishment Inspection Report (EIR)
• Field Alert Reports