Quality by Design (QbD) moves pharmaceutical development from a purely empirical approach toward a systematic understanding of the relationship between materials, process parameters, critical quality attributes and product performance.
A QbD-based program can help identify critical material attributes, critical process parameters, design space, process risks, control strategies and scale-up risks. FTF Pharma specifically lists QbD implementation as part of its pharmaceutical services, together with formulation development, technology transfer, new dosage forms and NCE formulation development.
QbD can be applied throughout product understanding, risk assessment, experimental design, process optimization, scale-up, control strategy and continued process verification.
QbD is most valuable when applied early. By understanding the relationship between process variables and product quality before commercial manufacturing, developers can reduce uncertainty and create more robust manufacturing processes.
