When it comes to quality control and process, the pharmaceutical industry has always been a reactive approach. If something is broken, then fixed, ie when a problem is the quality of the products, only then was performed. But now, to change things and the industry moves away from the control of product quality and after the flight to quality by design approach. This approach fits well with the dual purpose of reducing the production of waste, lean and continuous improvement. In 2003, the FDA Process Analytical Technology (PAT) “promotes the development and implementation of voluntary innovative pharmaceutical manufacturing and quality.” The aim of this initiative, the process efficiency, production and regulation is improving, and has four components: tools for data analysis, process analysis, process control and continuous feedback.
Initial efforts concentrated PAT in terms of development and application of analytical tools to measure the point in the process. But to fully realize the goal of understanding and control PAT entire production process, a wider range of instruments are used. The tools are recommended by the FDA multivariate tools (for managing the planning, collection and analysis), tools for process analysis tools and methods for monitoring the process of continuous improvement. So with these tools can develop
Pharmas UK on common objectives of the PAT, making the poor: reducing cycle time, less waste, increased automation and continuous process improvement.
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