critical quality attribute specification
IRI: https://spec.industrialontologies.org/ontology/construct/CriticalQualityAttributeSpecification
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/
SubClass Of: quality attribute specification
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › objective specification › output objective specification › quality attribute specification › critical quality attribute specification
Definition
quality attribute specification that prescribes some quality, capability, constitution, or composition deemed critical to ensuring the safety, efficacy, or performance of a material product
Explanatory Notes
1) From ICH: critical quality attribute is a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. The deviations of CQAs beyond defined limits have significant adverse impacts on product quality and, therefore, mandate stringent control, monitoring, and validation measures. 2) This specification serves as a formal constraint on a quality attribute that is critical to product performance, safety, or efficacy, and is used to assess the acceptability of materials or products in manufacturing and quality control processes. 3) Critical quality attributes are monitored throughout the manufacturing process and as such are measured on attributes of both final products and intermediate materials generated during the product production process.
Examples
- host-cell protein impurity specification in the clarified lysate; aggregate level specification for the purified monoclonal antibody; endotoxin level specification for the filled drug product; glycan profile specification for the monoclonal antibody drug substance
Adapted From
- https://database.ich.org/sites/default/files/Q8%28R2%29%20Guideline.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 criticality determination is missing
Formal Axioms
First-Order Logic Axioms
CriticalQualityAttributeSpecification(x) → QualityAttributeSpecification(x)
Semi-Formal Natural Language Axioms
if x is a ‘critical quality attribute specification’ then x is a ‘quality attribute specification’