Critical Process Parameters in Pharmaceutical Preparations | CPPs 

This video is about Critical Process Parameters in Pharmaceutical Preparations | CPPs
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What are
Critical Process Parameters (CPPs)?
A process parameter whose variability has an impact on a CQA and therefore should be monitored or controlled to ensure the process produces the desired quality. (ICH Q8).
During
development, process characterization studies identify the Critical (or Key)
Process Parameters (CPPs).
Critical Process parameters is a process input that, when varied beyond a limit range has an impact with significant influence on a critical quality attribute (CQA) and therefore should be monitored or controlled to ensure that the process produces the desired quality.
Examples of Critical Process Parameters (CPPs)
pH,
RPM
Particle size distribution
Temperature
time of material sterilization
Hold times
Time
Filtration Pressure
Fill volume
Filling speed
Nitrogen purging
Pressure
Sterilization time & Temperature
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