Consider the following scenario, a new pharmaceutical or biotech scientist or engineer is assigned the job of solving a problem, improving a process, or just developing better understanding how a process works. Five different people are asked for advice and guidance, and five different recommendations are received and summarized as – quality by design (QbD), process analytical technology (PAT), lean six sigma (LSS), design of experiments (DOE), and statistical process control (SPC). Each “advisor” has had success with their recommended approach. So what should this professional to do? Which approach should the professional use? First some context is needed to aid understanding of the five approaches.
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