certificate of analysis

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

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 analysis

Definition

certificate that provides quantitative results from analytical tests to verify that the attributes of a specific lot, batch, or individual product satisfy the requirement specifications stated in the certificate

Explanatory Notes

A Certificate of Analysis (CoA) includes numerical measurement results for one or more product attributes, in contrast to a Certificate of Conformance which may only indicate pass/fail status. A CoA also typically contains details such as the name and address of the laboratory, product specifications, testing procedures, and the signature and date of the approving authority. It is issued for a specific lot or batch and is commonly used as part of quality assurance and regulatory compliance documentation.

Examples

Certificate of Analysis for Sodium Acetate Trihydrate (Catalog No. SA-12345, Lot 2025-05-17-01) issued by ChemStandard Inc. on 2025-07-20. The certificate reports measured values for properties such as purity (99.6%), pH (8.4), and water content (39.7%), and confirms the material meets ACS Reagent Grade specification.

Counter-Examples

An internal lab notebook entry documenting the results of an experiment performed on a chemical compound; A certificate issued by a manufacturer stating that a product meets the requirements of a specific standard (e.g., ISO 9001), without including the results of any specific measurements performed on the material.

Adapted From

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html and EU GMP Guide Part I and ASTM E3077

Primitive Class

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

Primitive Rationale

This class is expected to remain primitive until a treatment of ternary relations is established. In particular, it is not currently possible to assert that the material certified by the document satisfies the requirements specified within the same certificate.

Formal Axioms

First-Order Logic Axioms

CertificateOfAnalysis(x) → Certificate(x) ∧ ∃q∃y((Disposition(q) ∨ Quality(q)) ∧ (MaterialProduct(y) ∨ Lot(y)) ∧ specificallyDependsOn(q, y) ∧
 ∃r(RequirementSpecification(r) ∧ hasContinuantPartAtAllTimes(x, r) ∧ requirementSatisfiedBy(r, q)) ∧
  ∃v(hasContinuantPartAtAllTimes(x, v) ∧ isMeasuredValueOfAtSomeTime(v, q)) ∧ certifies(x, y))

Semi-Formal Natural Language Axioms

If x is a ‘certificate of analysis’, then x is a ‘certificate’ such that there exists a ‘disposition’ or ‘quality’ q that ‘specifically depends on’ a ‘material product’ or ‘lot’ y, where x ‘has as continuant part at all times’ some ‘requirement specification’ that is ‘satisfied by’ q, and x also ‘has as continuant part at all times’ some value that is the ‘measured value of at some time’ q, and x ‘certifies’ y

Description Logic

constr:CertificateOfAnalysis ⊑ constr:Certificate

constr:CertificateOfAnalysis ⊑ ∃ bfo:has_continuant_part_at_all_times .∃ constr:isMeasuredValueOfAtSomeTime .((bfo:disposition ⊔ bfo:quality) ⊓ ∃ bfo:specifically_depends_on .(constr:Lot ⊔ constr:MaterialProduct))

constr:CertificateOfAnalysis ⊑ ∃ bfo:has_continuant_part_at_all_times .(constr:RequirementSpecification ⊓ ∃ constr:requirementSatisfiedBy .((bfo:disposition ⊔ bfo:quality) ⊓ ∃ bfo:specifically_depends_on .(constr:Lot ⊔ constr:MaterialProduct)))

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

SubClassOf: constr:Certificate

SubClassOf: bfo:has_continuant_part_at_all_times some constr:isMeasuredValueOfAtSomeTime some ((bfo:disposition or bfo:quality) and bfo:specifically_depends_on some (constr:Lot or constr:MaterialProduct))

SubClassOf: bfo:has_continuant_part_at_all_times some (constr:RequirementSpecification and constr:requirementSatisfiedBy some ((bfo:disposition or bfo:quality) and bfo:specifically_depends_on some (constr:Lot or constr:MaterialProduct)))

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