Quality By Design and the New Process Validation Guidance: A Report from IBC's Biopharmaceutical Development and Production Week

摘要

Where were you in 1987, and what were you doing? I'm not too embarrassed to say that I was beginning my last year of high school and paying far more attention to guitar lessons and writing my first novel than what I might eventually do for a career. Meanwhile, the US FDA was publishing a guidance document on process validation that the biopharmaceutical industry has relied on ever since. I'm willing to bet that quite a few readers of this issue weren't yet working in the industry at that time either— and one or two could even have been in the New England crowd with me at a Def Leppard concert that year.