When the job can be done consistently, then improvement can be made. The scientific methodology is the driving force to quality. The challenge is the need to implement FDA's risk approach.

Process analytical Technology (PAT) is a scientific risk-based framework to help pharmaceutical companies design, develop, and implement new efficient tools for use during product manufacture and quality assurance while maintaining or improving the current level of product quality assurance (FDA). PAT consists of two general components: 1) a set of scientific principles and tools supporting innovation and 2) a new regulatory strategy for accommodating innovation. It includes the PAT team approach. The primary focus of scientific manufacturing is to find new ways to use knowledge acquired during the processes and risk-based decisions. It is important for all team members to fully understand the processes and how they work.

With the team approach, work is standardized so each one knows...
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