White Paper

The concept of Quality by Design (QbD) is not a new idea but it is only in recent years that it has been considered for all aspects of the development process for pharmaceutical products. Even with this recent growth in interest, it can often be seen an unattractive prospect, for the reasons outlined below, and is not yet considered standard for the development of drugs and pharmaceuticals.

For those though that have taken the plunge and invested the time in developing analytical methodology for their products using QbD techniques, the advantages are being realized, reinforcing the future of QbD.

The current success, as applied to analytical test methods, relies heavily on a significant investment in laboratory time during the early stages of a product’s life cycle. For many, spending vital time designing a method from scratch instead of it being developed from a template of a similar product seems too time consuming and counterproductive. The time spent on design does, however, offer many advantages in terms of quality control and understanding of the methodology; this, in itself, provides long-term time and cost advantages.