compendial grade classifier
IRI: https://spec.industrialontologies.org/ontology/construct/CompendialGradeClassifier
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterial/
SubClass Of: material grade classifier
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › denoter › classifier › material grade classifier › compendial grade classifier
Direct subclasses:
Definition
material grade classifier that classifies a material entity as conforming to the requirements stated in an applicable pharmacopeial monograph
Explanatory Notes
A compendial grade classifier is used when the meaning of the grade is anchored in a pharmacopeial monograph rather than only in a supplier datasheet or internal specification. In this setting, compendial denotes that the material is associated with an official pharmacopeial standard and is expected to meet the monograph’s stated tests and acceptance criteria. Examples of pharmacopeias include USP and Ph. Eur.
Examples
- USP grade classification of a sodium chloride raw material lot; Ph. Eur. grade classification of a buffer component; compendial grade classification of an excipient lot against an applicable USP monograph; compendial grade classification of water for injection against an applicable pharmacopeial monograph;
Adapted From
- https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/generalNoticesandRequirementsFinal.pdf
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs for creating a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
CompendialGradeClassifier(x) → MaterialGradeClassifier(x)
Semi-Formal Natural Language Axioms
if x is a ‘compendial grade classifier’ then x is a ‘material grade classifier’