Quality by Design

Quality by Design (QbD) is a structured approach to process development that emphasizes science and risk management principles. Applying QbD allows companies to develop manufacturing processes that are safer and more compliant with CGMP regulations.

The fundamentals of the Quality by Design approach are:

  • Develop detailed process and product understanding from historical knowledge and product specific experimental data.
  • Use rationally designed experiments to develop a mathematical model for process parameters and product quality attributes.
  • Use risk management principles to guide process development. Use previous industry precedents as a resource.
  • Establish a rational control strategy based on product and process understanding. Focus on controlling points that are critical to the process and product quality.
  • Implement a lifecycle approach to process validation. Create rational process qualification requirements, use process development specifications for continued process verification, and analyze data for continual process improvement.

Implementing a Quality by Design approach can induce fear in employees and companies, especially when it leads them to deviate from their current approach and from industry precedents.

However, a strong Quality by Design structure and proper training will actually empower the process development team to design better experiments, create better process control schemes, and ultimately make better decisions in creating a safe, effective manufacturing process.