While many industries have moved to adopt the latest technologies and practices to improve their operational efficiency and lower costs of production, the pharmaceutical industry has been slow to keep pace, especially with respect to manufacturing.
The industry is still married to spreadsheets and fishbone diagrams for risk assessment and for understanding cause-and-effect relationships between process and product requirements. Here’s why those tools may no longer be sufficient.
As I talk to people about managing process development activities under a Quality-by-Design framework (QbD), people equate Quality-by-Design (QbD) with Design of Experiments (DOE). There are important differences.