CGMP IN A NUTSHELL

  • Know what you are supposed to do before you do it.
  • Document everything that occurs.
    • According to the FDA, “if it isn’t documented, it didn’t happen.”
  • Ensure consistency and control over all processes
  • Have an independent group make the final decision on a product to avoid bias.

 

cGMP in a Nutshell.png

GLP = Good Laboratory Practices

GCP = Good Clinical Practices

GMP = Good Manufacturing Practices