certificate of conformance

IRI: https://spec.industrialontologies.org/ontology/construct/CertificateOfConformance

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterialProcurementAndStorage/

SubClass Of: certificate

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › certificate › certificate of conformance

Definition

certificate issued by a manufacturer, supplier, or other authorized issuer that attests that a lot or batch or individual material product conforms to specified technical, safety, or regulatory requirements referenced in the certificate

Examples

• A supplier-issued CoC stating that a raw material lot conforms to the purchase specification and applicable compendial requirements; A manufacturer-issued CoC stating that a single-use bioreactor bag lot conforms to specified material, sterility, and extractables requirements; A CoC for a chromatography resin batch stating that it conforms to the supplier’s technical specification for particle size, ligand density, and bioburden; A CoC for a tubing lot stating that the material conforms to USP Class VI and relevant ISO biocompatibility requirements;

Primitive Class

This class is declared primitive and it does not have necessary and sufficient condiftions defined.

Primitive Rationale

There are insufficient constructs to create a set of necessary and sufficient conditions.

Formal Axioms

First-Order Logic Axioms

CertificateOfConformance(x) → Certificate(x) ∧ ∃y (certifies(x, y) ∧ (Lot(y) ∨ MaterialProduct(y)))

Semi-Formal Natural Language Axioms

if x is a ‘certificate of conformance’ then x is a ‘certificate’ and x ‘certifies’ some ‘lot’ or ‘material product’

Description Logic

constr:CertificateOfConformance ⊑ constr:Certificate

constr:CertificateOfConformance ⊑ ∃ constr:certifies .(constr:Lot ⊔ constr:MaterialProduct)

SubClassOf: constr:Certificate

SubClassOf: constr:certifies some (constr:Lot or constr:MaterialProduct)