The FDA’s recent guidance regarding Process Analytical Technology (PAT) offers the pharmaceutical and biotech industries an unprecedented opportunity to leverage hard-won experience with scientific inquiry and innovation. However, the leap to PAT is significant for even the most rigorous development program. Many aspects of Six Sigma; including its use of statistical tools and its phase- or toll-gate approach to project management, can facilitate and accelerate a PAT initiative. Rather than advocating company-wide Six Sigma adoption as a prerequisite to effective PAT implementation, an eight-phase Design for Lean Six Sigma approach is recommended that can be used on a project-by-project basis.
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