critical process parameters
- Guideline or reference source
- ICHQ12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
- ICHQ8 Pharmaceutical development
- 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
- Abbreviation for
- CPP
- Related Term
- alert limit
- critical
- critical process
- critical processing
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