Managing Risk and Driving Profitability with Today's Process Analytical Technologies in the Pharmaceutical Industry

Over the past few decades, terms such as Lean Six Sigma, Total Quality Management, and Continuous Improvement Strategy have become increasingly common in discussions of manufacturing plans. These techniques have one goal in common: to develop processes that maximize productivity and consistency and minimize risk to workers, consumers, and to the company. But each of those methods addresses specific aspects of manufacturing quality and efficiency. This whitepaper discusses the essential value a Quality by Design (QbD) approach brings to process design and identifies what process parameters most affect product quality, and which control strategies assure consistent quality production.