Trends in Pharma Manufacturing: Quality by Design(QbD)

Quality by Design (QbD) is a way of designing and developing manufacturing processes during the product development stage to continuously maintain a predefined quality till the end of the process. The term was mentioned in the International Conference on Harmonization (ICH), which states that “quality cannot be checked into products, but quality should be built in by design”. QbD is an emerging concept and best solution to build quality in all pharmaceutical products though it is also a major challenge to the pharmaceutical industries due to its fixed time processes and material variability. QbD can be implemented in various stages of drug development, which includes:

1. New therapeutic biological products/New Molecular Entity

  • Preclinical stage
  • Nonclinical stage
  • Clinical stage
  • Regulatory processes for market approval

2. Manufacturing landscape

  • Development of Design Space
  • Process Analytical Technology (PAT)
  • Real Time monitoring and Quality Control

3. Control Strategy

  • Consistent product performance
  • Risk based approaches
  • Constant improvement

Based on QbD principles, manufacturers must define desired product performance profile (TPP) and identify Critical Quality Attributes (CQAs). Also, product formulation and process to meet the product attributes can be designed. Finally, the impact of raw materials (critical material attributes (CMAs)) and critical process parameters (CPPs) on CQAs can be defined. QbD is the futuristic idea of pharma manufacturers, which offers self-regulated flexibility along with quality standards and real time release of the drug product.

Benefits of implementing QbD:

  • Decreased batch failures
  • Better process understanding
  • Return of investment/cost savings
  • Minimal regulatory compliance problems
  • Time to market reductions