Quality by design(QbD) approach

“The Quality cannot be tested into the product, but it should be built into it.” QbD can be attributed as a Scientific, risk-based, holistic and proactive approach to the development of a pharmaceutical product. It is more of a deliberate design effort from product conception through commercialization requiring full understanding of how product attributes and process would relate to product performance. In FDA’s Office of New Drug Quality Assessment (ONDQA), a new risk-based pharmaceutical quality assessment system (PQAS) was established based on the application of product and process understanding. The difference between QbD for NDA and ANDA products is most apparent at the first step of the process. For an NDA, the target product profile is under development while for the ANDA product the target product profile is well established by the labeling and clinical studies conducted to support the approval of the reference product.

  • QRM :Quantitative Risk Management
  • Uni/multi variant experiments
  • Measurement capability
  • CPPs :Critical Process Parameters
  • CQAs : Critical Quality Attributes
  • Process Performance & Product Quality Monitoring System
  • ICH Q8 and Q8(R)
  • ONDQA QbD Pilot Program
  • Challenges of Implementing QbD

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