Critical Process Parameter (CPP)

Definition

A Critical Process Parameter is a process variable, such as temperature, mixing time, or pressure, whose variability has a direct impact on a Critical Quality Attribute, and which must therefore be monitored and controlled within an established range to ensure the product consistently meets its quality requirements.

Benefits

Identifying and tightly controlling CPPs within an EBR system allows manufacturers to catch process drift in real time, rather than discovering a quality issue only after finished product testing, supporting both product quality and the broader move toward real-time release.

Use Case

During process development, a biotech company identifies bioreactor temperature as a CPP affecting product yield and purity. The EBR system is configured to require operator confirmation and automatically flag any reading outside the validated range during production.

Frequently Asked Questions (FAQ)

Related Terms

• Critical Quality Attribute (CQA)
• In-Process Control (IPC)