Question

Explain the concept of Quality by Design. What technologies enable the realization of QbD? Describe what the following terms and the role they play in realizing QbD: failure mode and effects analysis, design space, statistical experimental design, process control systems, process analytics, and multivariate data analysis. Please provide references

Answer 1

QBD

Definition - Systemic approach to developemet that begins with predefined objectives and emphazises product and procss understanding and process control ,based on sound science and quality risk management.

Concept- Quality by design is a concept first outlined by Joseph M Juran in various publications. He supposed that quality could be planned. The concept of QBD states that "to identify quality can not be tested be tested in products, i.e. quality should be built into product by design."

Two very important practical aspects of QBD implementation are

1. Availability of on demand data access that automatically accounts for batch genealogy in upstream downstream correlations and

2. The specific requirement for flexible data access in process developement for design space work.

These are made possible by the today's technologies like

computational fluid dynamics

multivariate data analysis

use of high-throughput approaches

process analytical technology base controls.