acceptance criteria
IRI: https://spec.industrialontologies.org/ontology/construct/AcceptanceCriteria
Defined In: https://spec.industrialontologies.org/ontology/biopharma/ReferenceOntologyCandidates/
SubClass Of: requirement specification
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › requirement specification › acceptance criteria
Definition
requirement specification that has as parts one or more limits, ranges, or other conditions used to determine whether an entity is acceptable for a specified purpose
Explanatory Notes
1) In the ICH specifications (Q6B) context, acceptance criteria are defined as “numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures” (applying to drug substance, drug product, or materials at other manufacturing stages). 2) In a process-validation context, protocols are expected to include tests and acceptance criteria for significant processing steps, i.e., criteria used to judge whether process performance is acceptable.
Examples
- An analytical specification for a drug substance has as part acceptance criteria requiring residual host cell protein to be not more than 100 ng/mg protein; A batch release specification has as part acceptance criteria requiring product purity to be at least 95 %; A drug product specification has as part acceptance criteria requiring endotoxin to be not more than 0.25 EU/mL; An acceptance criterion for PVC resin intended for general-purpose applications requires residual vinyl chloride to be less than 1 ppm; An acceptance criterion for drinking water requires lead concentration to be not more than 15 ppb.
Adapted From
- https://database.ich.org/sites/default/files/Q6B%20Guideline.pdf and https://www.fda.gov/files/drugs/published/Process-Validation–General-Principles-and-Practices.pdf
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 necessary and sufficient conditions. In particular, constructs for exhaustively representing conditions that are parts of acceptance criteria are missing.
Formal Axioms
First-Order Logic Axioms
AcceptanceCriteria(x) → RequirementSpecification(x)
Semi-Formal Natural Language Axioms
if x is an ‘acceptance criteria’ then x is a ‘requirement specification’