process trending analysis
IRI: https://spec.industrialontologies.org/ontology/construct/ProcessTrendingAnalysis
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingProcessLifecycle/
SubClass Of: planned process
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › process trending analysis
Definition
planned process that systematically analyzes historical and/or current process and quality data to identify patterns, shifts, drifts, or abnormal variability in process parameters, material attributes, quality attributes, or performance indicators within and/or between batches
Explanatory Notes
Process trending analysis commonly occurs as part of continued process verification but may also support manufacturing process characterization, investigation, product quality review, comparability assessment, process improvement, and other lifecycle activities. It may evaluate process parameters, material attributes, quality attributes, performance indicators, deviations, yields, or other relevant process and product data using statistical or qualitative trending methods.
Examples
- process trending analysis evaluates viable cell density, culture duration, product titer, aggregate level, and glycosylation results across consecutive commercial monoclonal antibody batches to identify gradual process drift and changes in inter-batch variability
Adapted From
- https://www.fda.gov/media/71021/download
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs present to represent necessary and sufficient conditions.
Formal Axioms
First-Order Logic Axioms
ProcessTrendingAnalysis(x) → PlannedProcess(x)
Semi-Formal Natural Language Axioms
if x is a ‘process trending analysis’ then x is a ‘planned process’