A physical, chemical, biological or microbiological property or characteristic of an input material that should be within an appropriate limit, range, or distribution to ensure the desired quality of output material. This guidance discusses the term critical process parameter (cpp) and considerations are described for identifying the cpps that need validation The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a cqa is large enough to make a practically meaningful impact (i.e., practical significance).
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This review provides information on objectives and benefits of process validation, and impact of critical process parameters on critical quality attributes of solid dosage form are also discussed.
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. A critical process parameter (cpp) is a term used in pharmaceutical production for process variables which have an impact on a critical quality attribute (cqa) and, therefore, should be monitored or controlled to ensure the drug product obtains the desired quality. A process parameter whose variability has an impact on a critical quality attribute and must be monitored or controlled to ensure the process produces the desired quality (ich q8(r2)). The definition for cpp states that a parameter is considered critical when its variability has an impact on a cqa
The amount of impact is not defined, which leads to the question, does even a small impact to a cqa mean that the parameter is critical? Critical quality attributes (cqas) and critical process parameters (cpps) are integral to maintain product quality and are extensively managed throughout the product lifecycle.
