<P> Critical process parameters (CPP) in pharmaceutical manufacturing are key variables affecting the production process . CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in Critical Quality Attributes . Those attributes with a higher impact on CQAs should be prioritized and held in a stricter state of control . The manufacturer should conduct test to set acceptable range limits of the determined CPPs and define acceptable process variable variability . Operational conditions within this range are considered acceptable operational standards . Any deviation from the acceptable range will be indicative of issues within the process and the subsequent production of substandard products . Data relating to CPP should be recorded, stored, and analyzed by the manufacturer . CPP variables and ranges should be reevaluated after careful analysis of historical CPP data . Identifying CPPs is done in stage one of Process Validation: Process design are an essential part of a manufacturing control strategy . </P> <P> One method of defining CPPs is to look at the effect of certain production processes on critical quality attributes . Those production parameters which have a measurable effect on those quality attributes that have been identified as critical can be considered CPPs and must always be in a state of control . </P>

Name the critical process parameters in validation of mixing