It is important for each manufacturer to define what is critical to each API process. If you deviate
from something that you have defined as a critical parameter, then that becomes a critical
deviation.
Unfortunately, as companies continue to run a process over the years, they learn about the
process and uncover new factors or parameters that they had not originally identified as critical,
that indeed affect API quality. So it’s important to continue to update your list of critical
parameters with knowledge that you acquire over the years. That’s part of the purpose of the
Product Quality.
