Critical Process Parameters | Guidelines For CPPs | Examples Of CPPs

Critical process parameters are process variables which have an impact on product quality.The process or equipment variables may be the time, pressure,speed and temperature.Critical process parameters are those parameters which must be kept within specified limits or range and they have impact on critical quality attributes or CQAs.Various guidelines focus on CPPs including ICH Q8, Q9,Q10 and Q11.
The critical process parameters are identified by the following
Identifying CQAs
Risk assessment
Design of experiments
Critical process parameters are of great importance as they give us assurance about product quality,process reliability and consistency.
The examples of critical process parameters are also discussed in this video so watch the complete video.
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Check interview questions playlist