ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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General Process Parameter (GPP)

(CMC-BWG) An adjustable parameter (variable) of the process that does not have a meaningful effect on product quality or process performance. A key process parameter does not affect critical product quality attributes. Ranges for GPPs are established during process development, and changes to operating ranges will be managed within the quality system.

Publication Source: Food and Agricultural Organization of the United Nations (FAO)
Publication Date: 1999

See also: Key Process Parameter (KPP)

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