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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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