According to the FDA, the goal of Process Analytic Technology (PAT) is to understand and control the manufacturing process, which is consistent with the current drug quality system, which states, quality cannot be tested into products, it should be built in or should be by design.
The road to operational excellence can be challenging, especially for those in heavily regulated industries. Whether you are using a Kaizen approach to deal with equipment effectiveness or using Six Sigma to decrease variability, Continuous Improvement can be approached from many angles and does not come with a roadmap. In this whitepaper we explore the various approaches to getting the most out of your Pharmaceutical manufacturing operation, and how to:
- Create focused and achievable goals
- Automate KPI-based metrics
- Identify Root causes of production losses
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