material sampling plan
IRI: https://spec.industrialontologies.org/ontology/construct/MaterialSamplingPlan
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMonitoringAndControl/
SubClass Of: plan specification
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › plan specification › material sampling plan
Definition
plan specification that prescribes how, when and how often material samples are to be taken
Explanatory Notes
1) A material sampling plan in the context of production and quality management refers to a documented strategy that defines how, when, and how often samples are to be taken from materials, products, or processes for testing or inspection. 2) Key aspects of a material sampling plan include: Frequency: Specifies how often material samples should be taken (e.g., every batch, every tenth delivery, or at regular time intervals). Sample Size: Defines the number or quantity of items to be sampled at each interval.
Examples
- Material sampling plan that prescribes in-process sampling on Days 5, 7, and 9 for glycan profiling of the expressed monoclonal antibody; Material sampling plan that prescribes post-harvest sampling to assess product titer and host cell protein levels before downstream purification; Material sampling plan that prescribes manual collection of 20 tablets per batch for disintegration and hardness testing in the QC lab; Material sampling plan that prescribes taking an aliquot from every third eluate fraction during protein A chromatography for titer and impurity analysis (HCP and DNA)
Synonyms
- sample plan
- sampling strategy
Adapted From
- https://itl.nist.gov/div898/handbook/ppc/section3/ppc33.htm
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs in this release to fully capture the structure of a material sampling plan
Formal Axioms
First-Order Logic Axioms
MaterialSamplingPlan(x) → PlanSpecification(x) ∧ ∃y(MaterialSamplingProcess(y) ∧ prescribes(x, y))
Semi-Formal Natural Language Axioms
if x is a ‘material sampling plan’, then x is a ‘plan specification’ that ‘prescribes’ some ‘material sampling process’