The Quality by Design (QbD) term was originally introduced in the pharmaceutical lexicon in 2005 via ICH Q8(R2) and additionally described in ICH Q9 and Q10. [1] In essence, QbD is a systematic risk management approach which emphasizes maximum product-, process-understanding, and process control in contrast to a trial and error-based quality control approach that banks on success primarily via end stage product testing. [2]
Read on