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Terminology Definitions for Pharma, Biopharma, and Medical Device Industries

Critical Process Parameter

What is a Critical Process Parameter?

Abbreviation: CPP

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Critical process parameters are the key variables affecting the production process that must be controlled within specific limits to ensure that critical quality attributes (CQAs) are consistently achieved. In pharma manufacturing, CPPs are identified during process development and are closely monitored because they directly impact the quality and safety of the final product. Effective control of CPPs ensures the product meets its intended standards. Examples of CPPs might include temperature, pressure, and pH levels during a manufacturing process.

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