Process Validation: Process Design

Lesson Code: BPU-1111 (PREMIUM LESSON) An overview of the process design stage of process validation, describing how a biopharmaceutical manufacturing process can be defined using a Quality by Design (QbD) approach that emphasizes accumulated scientific knowledge and quality risk management.

  • Category: Biopharma Processes and Equipment


After taking this e-Lesson, you will be able to:

  • Describe the rationale for having a structured approach to Process Design
  • Explain what is meant by 'Quality by Design'
  • Explain the concept of a 'Quality Target Product Profile'
  • Define Critical Quality Attribute (CQA) and provide some examples
  • Explain why risk assessment is done as part of process design
  • Explain the concept of manufacturing 'design space' with reference to Design of Experiments and Critical Process Parameters
  • Define Process Control Strategy and Operational Control Strategy
  • Define Master Production Record and explain its relationship to Process Design studies