No Margin for Error: FDA Lessons on GMP Compliance
The drugs we produce constantly evolve. But one essential ingredient remains unchanged year-after-year: Quality.
At its heart, our industry is about saving and improving lives. That’s what draws people into this business in the first place. But sometimes people need reminding about that. That’s what this classic training DVD has been doing for years, with powerful stories that remind people exactly how GMP compliance affects real life.
The FDA produced No Margin for Error in 1967 to highlight what can happen when GMPs are not followed. The two-part program deals with the manufacture of a fictitious hydrocortisone drug, Steroid 47.
In part one, we see poor manufacturing practices being followed, with the vivid reminder that, in the long run, it is very costly not to use GMP.
In part two, the manufacturing process is repeated, this time following GMP. We see the results of proper planning, supervisors determined to "do the job the right way," and following procedures to ensure error-free production. This segment emphasizes how all manufacturing personnel are critical to the production process.