This paper aims to show how the use of advanced QFD Design Matrices with integrated use of Axiomatic Design can increase effectiveness and speed of knowledge creation in pharmaceutical process development. Traditionally regulatory bodies required pharma manufacturers to keep their processes fixed once a drug had been approved. In recent years this mindset started to change fundamentally, inspired by insights delivered by a growing Lean Six Sigma community. Risk management and statistical process control are now accepted as elements of Good Manufacturing Practice (GMP). “Quality by Design” is defined as "a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management".
Using QFD in Pharmaceutical Quality by Design
Arcidiacono G
2011-01-01
Abstract
This paper aims to show how the use of advanced QFD Design Matrices with integrated use of Axiomatic Design can increase effectiveness and speed of knowledge creation in pharmaceutical process development. Traditionally regulatory bodies required pharma manufacturers to keep their processes fixed once a drug had been approved. In recent years this mindset started to change fundamentally, inspired by insights delivered by a growing Lean Six Sigma community. Risk management and statistical process control are now accepted as elements of Good Manufacturing Practice (GMP). “Quality by Design” is defined as "a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management".I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
