{"id":40395,"date":"2026-10-29T16:25:34","date_gmt":"2026-10-29T16:25:34","guid":{"rendered":"https:\/\/dev.accevo.com\/blog\/critical-process-parameters-in-pharma-cpps-quality-and-control\/"},"modified":"2026-10-29T16:25:44","modified_gmt":"2026-10-29T16:25:44","slug":"critical-process-parameters-pharma","status":"publish","type":"post","link":"https:\/\/accevo.com\/pl\/blog\/critical-process-parameters-pharma\/","title":{"rendered":"Critical Process Parameters in Pharma: CPPs, Quality and Control"},"content":{"rendered":"

A critical process parameter (CPP) is a process variable whose variation can affect a critical quality attribute, and which therefore needs monitoring or control.<\/strong> In pharmaceutical manufacturing, the classification depends on the product and process: temperature, mixing time or pressure is not automatically a CPP simply because the team measures it.<\/p>\n

\"AI-generated<\/p>\n

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Critical process parameters and critical quality attributes<\/h2>\n

ICH Q8(R2)<\/a> defines a CPP through the effect of its variability on a critical quality attribute (CQA). A CQA is a physical, chemical, biological or microbiological property that should stay within an appropriate limit, range or distribution to achieve the desired product quality.<\/p>\n

Process development and quality teams investigate the relationship between a parameter and an attribute. They use process knowledge, experiments and risk assessment to decide whether the parameter is critical and how to control it. A variable that matters for throughput or equipment protection may still need attention, even if its relationship to a CQA does not make it a CPP.<\/p>\n

\"Illustrative<\/p>\n

Illustrative relationship. A parameter’s classification depends on evidence for the specific product and process.<\/p>\n

Examples of potential CPPs in pharma<\/h2>\n

The examples below are illustrative starting points for an assessment. They are not classifications or operating limits for a real product. A site must establish the relationship to its own CQAs and process:<\/p>\n