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
Description
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
