quality target product profile
IRI: https://spec.industrialontologies.org/ontology/construct/QualityTargetProductProfile
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaManufacturingProcessLifecycle/
SubClass Of: requirement specification
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › requirement specification › quality target product profile
Definition
requirement specification that represents a prospective summary of the quality characteristics of a product that should ideally be achieved to ensure the desired quality, taking into account the safety and efficacy of that product
Explanatory Notes
The quality target product profile forms the basis of design for development of a drug product by providing a prospective summary of the drug product quality characteristics that should ideally be achieved to ensure the desired quality. Typical considerations include the intended clinical use, the route of administration, the dosage form and delivery system, the dosage strength or strengths, the container closure system, therapeutic moiety release or delivery characteristics, and attributes affecting pharmacokinetics such as dissolution performance or aerodynamic performance as appropriate to the dosage form. Considerations also include drug product quality criteria appropriate for the intended marketed product, such as sterility, purity, stability, and drug release.
Examples
- quality target product profile (QTPP) for a sterile injectable monoclonal antibody drug product specifying the intended route of administration, dosage strength, sterility expectations, potency, purity, stability, and container-closure quality characteristics; quality target product profile (QTPP) for an oral solid dosage drug product specifying the intended dosage form, dosage strength, dissolution performance, impurity expectations, stability, and appearance; quality target product profile (QTPP) for an inhalation drug product specifying the intended delivery system, delivered dose, aerodynamic particle-size performance, purity, and stability
Adapted From
- https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-considerations-ich-guideline-q8-r2-pharmaceutical-development-step-5_en.pdf
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
This term is expected to remain primitive.
Formal Axioms
First-Order Logic Axioms
QualityTargetProductProfile(x) → RequirementSpecification(x) ∧ ∃q (hasContinuantPartAtAllTimes(x, q) ∧ QualityAttributeSpecification(q))
Semi-Formal Natural Language Axioms
if x is a ‘quality target product profile’ then x is a ‘requirement specification’, x ‘has continuant part at all times’ some ‘quality attribute specification’
Description Logic
constr:QualityTargetProductProfile ⊑ constr:RequirementSpecification
constr:QualityTargetProductProfile ⊑ ∃ bfo:has_continuant_part_at_all_times .constr:QualityAttributeSpecification
SubClassOf: constr:RequirementSpecification
SubClassOf: bfo:has_continuant_part_at_all_times some constr:QualityAttributeSpecification