ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Key Process Parameter (KPP)

(CMC-BWG) An adjustable parameter (variable) of the process that, when maintained within a narrow range, ensures optimum process performance. A key process parameter does not meaningfully affect critical product quality attributes. Ranges for KPPs are established during process development, and changes to operating ranges will be managed within the quality system.

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See also: General Process Parameter (GPP)

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