Critical Process Parameter (CPP)

Critical Process Parameter(CPP)

CMC

Definition

A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.

Regulatory source

ICH Q8(R2), process validation guidance

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Critical Process Parameter(CPP)

CMC

Definition

A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.

Regulatory source

ICH Q8(R2), process validation guidance