Biopharma Material Testing Ontology
This module supports representation of material testing activities used to determine whether a material is acceptable for its intended use. It connects testing processes, analytical evidence, specifications, acceptance criteria, out-of-specification results, and release dispositions so that material quality and suitability can be described consistently across incoming materials, process intermediates, consumables, and products.
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culture media fingerprinting
Raman spectroscopic characterization of a culture medium lot to generate a spectral fingerprint for comparison with a reference lot; LC-MS-based characterization of a culture medium preparation to generate a multivariate compositional profile used for identity assessment
An identity or consistency assessment commonly compares profiles from different preparations of the same nominal culture medium, such as different lots, sublots, or in-house compounded preparations.
CultureMediaFingerprinting(x) → MeasurementProcess(x) ∧ ∃m (hasInput(x, m) ∧ CultureMedium(m))
measurement process in which a culture medium is characterized by one or more analytical methods to generate a multivariate profile that can be used to assess identity or consistency
There are insufficient constructs to create a set of necessary and sufficient conditions.
if x is a 'culture media fingerprinting' then x is a 'measurement process' and x 'has input' some 'culture medium'
material conformance specification
drug substance release specification that includes identity, purity, potency, endotoxin, and bioburden tests and their acceptance criteria; in-process specification for a chromatography pool that includes protein concentration, purity, pH, conductivity, and bioburden tests and their acceptance criteria; incoming raw material specification for a media powder lot that includes identity, appearance, composition, moisture, impurity, and microbial tests and their acceptance criteria; prepared culture medium specification that includes pH, osmolality, appearance, endotoxin, bioburden, and cell-growth performance tests and their acceptance criteria
1) Each listed test is intended to evaluate one or more attributes of the material, such as identity, purity, concentration, bioburden, endotoxin, or osmolality. A listed test references an analytical procedure that specifies how the relevant measurements are produced, while the associated acceptance criteria specify how those measurement or observation results are evaluated for conformance. 2) This specification type covers release, in-process, incoming or raw-material, and production-consumable acceptance specifications, provided they specify tests and acceptance criteria for evaluating the acceptability of the material for a stated use.
MaterialConformanceSpecification(x) → RequirementSpecification(x) ∧ ∃p (hasContinuantPartAtAllTimes(x, p) ∧ PlanSpecification(p) ∧ ∃t (prescribes(p, t) ∧ MaterialTestingProcess(t))) ∧ ∃a (hasContinuantPartAtAllTimes(x, a) ∧ AcceptanceCriteria(a)) ∧ ∀y (requirementSatisfiedBy(x, y) → (MaterialProduct(y) ∨ ProcessIntermediateMaterial(y) ∨ ProductionConsumable(y) ∨ RawMaterial(y)))
requirement specification that specifies tests and acceptance criteria for evaluating the acceptability of a material product, process intermediate material, raw material, or production consumable for a particular use
if x is a 'material conformance specification' then x is a 'requirement specification', x 'has continuant part at all times' some 'plan specification' that 'prescribes' some 'material testing process', x 'has continuant part at all times' some 'acceptance criteria', and x 'requirement satisfied by' only 'material product', 'process intermediate material', 'production consumable', or 'raw material'
material conformance testing process
release testing of a drug substance batch against identity, purity, potency, endotoxin, and bioburden tests and their acceptance criteria; in-process testing of a chromatography pool against protein concentration, purity, pH, conductivity, and bioburden tests and their acceptance criteria; incoming testing of a culture media powder lot against identity, appearance, composition, moisture, impurity, and microbial tests and their acceptance criteria; testing of a prepared culture medium lot against pH, osmolality, appearance, endotoxin, bioburden, and cell-growth performance tests and their acceptance criteria
MaterialConformanceTestingProcess(x) ↔ MaterialTestingProcess(x) ∧ ∃s(MaterialConformanceSpecification(s) ∧ hasInput(x,s)) ∧ ∃m((MaterialProduct(m) ∨ ProcessIntermediateMaterial(m) ∨ ProductionConsumable(m) ∨ RawMaterial(m)) ∧ hasInput(x,m))
material testing process that evaluates a material product, process intermediate material, raw material, or production consumable against acceptance criteria specified by a material conformance specification
every instance of 'material conformance testing process' is exactly an instance of 'material testing process' that 'has input' some 'material conformance specification' and 'has input' some entity that is a 'material product', 'process intermediate material', 'production consumable', or 'raw material'
material hold state
the hold state of a raw-material lot pending release for use in media preparation; the hold state of a chromatography pool pending authorization for further processing; the hold state of a drug-substance batch pending release for formulation; the hold state of a finished-product batch pending release for distribution
1) Material hold state should not be confused with the held or hold state of equipment in an ISA-88 state model, in which equipment is brought to a predefined safe condition in response to an abnormal or exception condition. 2) Material hold state does not include the temporary retention of work-in-process material in a vessel or container solely while awaiting downstream processing capacity or equipment availability.
material state during which a material entity remains restricted from one or more specified uses or handling activities
There are insufficient constructs for creating a set of necessary and sufficient conditions.
if x is a 'material hold state' then x is a 'material state'
material performance testing process
small-scale performance testing of a culture-medium lot by preparing the medium according to a specified procedure, using it in a controlled mammalian cell-culture process, and evaluating viable cell density, viability, growth rate, and product titer against specified performance criteria; performance testing of a chromatography-resin lot by packing the resin into a small-scale column, operating it under specified loading, washing, and elution conditions, and evaluating dynamic binding capacity, product recovery, impurity clearance, and pressure-flow behavior against specified performance criteria
The assertion that an input material entity has the capability evaluated by a material performance testing process does not imply that the capability is adequate for the intended application or that the material meets the applicable performance criteria. The testing may produce a favorable, unfavorable, or inconclusive assessment of the capability.
MaterialPerformanceTestingProcess(x) → MaterialTestingProcess(x) ∧ ∃m∃c∃t(MaterialEntity(m) ∧ hasInput(x,m) ∧ Capability(c) ∧ hasCapability(m,c) ∧ MaterialTestingInformationContentEntity(t) ∧ hasSpecifiedOutput(x,t) ∧ describes(t,c))
material testing process that evaluates a capability of the input material entity through its use in a specified process or its exposure to specified test conditions
if x is a 'material performance testing process' then x is a 'material testing process' that 'has input' some 'material entity' that 'has capability' some 'capability' and 'has specified output' some 'material testing information content entity' that 'describes' that 'capability'
material release disposition specification
QA disposition specifying that raw-material lot RM-041 may be used in media preparation; material disposition specifying that process-intermediate lot INT-204 must remain on hold pending completion of an OOS investigation; material disposition specifying that drug-substance batch DS-117 may be used in formulation;
https://database.ich.org/sites/default/files/Q7%20Guideline.pdf and https://pharmagmpguide.com/raw-material-receipt-sop-in-pharma/ and https://sgsystemsglobal.com/glossary/batch-release/ and https://sgsystemsglobal.com/glossary/lot-release-qa-disposition/
The post material state specified by a material release disposition specification represents the status assigned to the evaluated material with respect to the relevant use, such as release from hold, conditional release, continuation of hold, or rejection.
MaterialReleaseDispositionSpecification(x) ↔ MaterialStateSpecification(x) ∧ ∃p∃m∃s(MaterialReleaseProcess(p) ∧ isSpecifiedOutputOf(x,p) ∧ hasInput(p,m) ∧ (MaterialProduct(m) ∨ ProcessIntermediateMaterial(m) ∨ ProductionConsumable(m) ∨ RawMaterial(m)) ∧ MaterialState(s) ∧ hasPostMaterialState(p,s) ∧ isMaterialStateOf(s,m) ∧ prescribes(x,s))
material state specification that is a specified output of a material release process and specifies the post material state of the evaluated material entity with respect to a particular use
every instance of 'material release disposition specification' is defined as exactly an instance of 'material state specification' that 'is specified output of' some 'material release process' p that 'has input' some entity m that is a 'material product', 'process intermediate material', 'production consumable', or 'raw material', and 'prescribes' some 'material state' s that is the 'post material state' of p and 'is material state of' m
material release process
release of an incoming raw material lot for use in media preparation following identity and purity testing; evaluation of a production consumable against receipt inspection results and supplier documentation resulting in rejection for GMP manufacturing use; release of a process intermediate for further processing following assessment of test results and process records; release of a drug substance batch for use in formulation; conditional release of a material lot for a restricted use
A material release process may involve a material entity such as an individual item, material unit, lot, batch, or another material grouping under evaluation. Exiting quarantine or another controlled hold does not necessarily mean that the material is used immediately; it means that the material is no longer restricted from the particular use for which the assessment was performed and may be stored, transferred, or otherwise made available for that use in accordance with applicable procedures. The assessment may include review of identity, sampling, testing, examination, documentation, and other specified criteria. ICH Q7 requires materials to be held under quarantine until they have been sampled, examined or tested as appropriate and released for use.
MaterialReleaseProcess(x) → PlannedProcess(x) ∧ ∃a∃q∃m∃h∃s∃d(Agent(a) ∧ hasParticipantAtSomeTime(x,a) ∧ MaterialConformanceSpecification(q) ∧ hasInput(x,q) ∧ (MaterialProduct(m) ∨ ProcessIntermediateMaterial(m) ∨ ProductionConsumable(m) ∨ RawMaterial(m)) ∧ hasInput(x,m) ∧ MaterialHoldState(h) ∧ hasPreMaterialState(x,h) ∧ isMaterialStateOf(h,m) ∧ MaterialState(s) ∧ hasPostMaterialState(x,s) ∧ isMaterialStateOf(s,m) ∧ MaterialReleaseDispositionSpecification(d) ∧ hasSpecifiedOutput(x,d) ∧ prescribes(d,s))
planned process in which a material entity, together with relevant evidence, is assessed against specified requirements to determine whether, and under what conditions, the material entity may exit quarantine or another controlled hold and be made available for a particular use
if x is a 'material release process' then x is a 'planned process' that 'has participant at some time' some 'agent', 'has input' some 'material conformance specification', 'has input' some 'material product', 'process intermediate material', 'production consumable', or 'raw material' m, 'has pre material state' some 'material hold state' that 'is material state of' m, 'has post material state' some 'material state' s that 'is material state of' m, and 'has specified output' some 'material release disposition specification' that 'prescribes' s
material stability testing process
stability testing of a drug substance batch after refrigerated storage to determine whether purity, potency, and appearance remain within specified stability criteria; stability testing of a formulated drug product after storage at long-term and accelerated conditions to determine whether assay, degradation products, pH, and visible particles remain within specified criteria; stability testing of a cell culture medium lot after storage at 2–8 °C to determine whether pH, osmolality, appearance, and key nutrient concentrations remain within specified limits;
MaterialStabilityTestingProcess(x) → MaterialTestingProcess(x) ∧ ∃m∃s∃o(MaterialEntity(m) ∧ hasInput(x,m) ∧ Stability(s) ∧ hasCapability(m,s) ∧ MaterialTestingInformationContentEntity(o) ∧ hasSpecifiedOutput(x,o) ∧ describes(o,s))
material testing process that evaluates the capability of an input material entity to maintain one or more specified attributes or performance characteristics over time under specified conditions
There are insufficient constructs present to create a set of necessary and sufficient conditions.
if x is a 'material stability testing process' then x is a 'material testing process' that 'has input' some 'material entity' m that 'has capability' some 'stability' s and 'has specified output' some 'material testing information content entity' that 'describes' that same 'stability' s
material test assessment
a material test assessment that records 'within limit' after the pH measured on a representative sample of a prepared buffer lot is evaluated against the release criterion of pH 6.8 to 7.2; a material test assessment that records 'identity confirmed' after the infrared spectrum and specified chemical-reaction results obtained from a representative sample of a raw-material lot are evaluated against the identity criteria prescribed by the test method; a material test assessment that records 'inconclusive' after finished-product sterility testing because the required growth is not observed in the positive-control vessels, preventing a valid interpretation of the absence of microbial growth in the product test vessels
1) The value expression of a material test assessment records the outcome of the evaluation, such as within limit, outside limit, pass, fail, identity confirmed, detected, not detected, or inconclusive. 2) A material test assessment is distinct from its value expression. The assessment identifies the measurement information evaluated and the testing criterion applied, while the value expression records the resulting outcome category. In the future a categorical value expression will be developed to strengthen the distinction. 3) A material test assessment is also distinct from a material testing information content entity. A material testing information content entity represents the broader informational result of a material test and may contain multiple measurement information content entities and material test assessments. 4) A material test assessment may be about a measurement information content entity or one or more measured value expressions. A measured value expression should be used when the assessment concerns a particular value within measurement information containing several values. The measurement information content entity should be used when a spectrum, profile, image, curve, observation record, or other measurement output is evaluated as a whole. 5) The reporting of a measurement result alone does not constitute a material test assessment. A material test assessment requires the measurement result to be evaluated against a specified testing criterion as part of a material testing process. For example, recording the pH of a bioreactor during processing is measurement or monitoring, whereas evaluating a laboratory pH result from a material sample against a release criterion produces a material test assessment. 6) A material test assessment is an information content entity, not the process of performing the evaluation. The evaluation process produces or informs the material test assessment.
MaterialTestAssessment(x) → InformationContentEntity(x) ∧ ∃r∃m∃v(RequirementSpecification(r) ∧ isAbout(x,r) ∧ (MeasurementInformationContentEntity(m) ∨ MeasuredValueExpression(m)) ∧ isAbout(x,m) ∧ ValueExpression(v) ∧ hasValueExpressionAtAllTimes(x,v))
information content entity that records the outcome of evaluating measurement results against a specified testing criterion
if x is a 'material test assessment' then x is an 'information content entity' that 'is about' some 'requirement specification', 'is about' some entity that is a 'measurement information content entity' or a 'measured value expression', and 'has value expression at all times' some 'value expression'
material testing information content entity
a sterility test record containing growth observations for the product and controls and an overall test assessment; a package-integrity test record containing vacuum-decay measurements and a pass or fail assessment
1) Material testing information content entity describes the tested material entity, quality, or capability and contains measurement information and material test assessments resulting from the testing. 2) Testing criteria are currently represented using requirement specifications that are connected to the material test assessment by 'is about'. In the future a dedicated testing criteria class might be introduced.
MaterialTestingInformationContentEntity(x) ↔ InformationContentEntity(x) ∧ ∃p∃y∃m∃a(MaterialTestingProcess(p) ∧ isSpecifiedOutputOf(x,p) ∧ (MaterialEntity(y) ∨ Capability(y) ∨ Quality(y)) ∧ describes(x,y) ∧ MeasurementInformationContentEntity(m) ∧ hasContinuantPartAtAllTimes(x,m) ∧ MaterialTestAssessment(a) ∧ hasContinuantPartAtAllTimes(x,a))
information content entity that is the result of testing a material entity or one or more of its attributes against specified testing criteria
every instance of 'material testing information content entity' is exactly an instance of 'information content entity' that 'is specified output of' some 'material testing process', 'describes' some entity that is a 'material entity', 'capability', or 'quality', 'has continuant part at all times' some 'measurement information content entity', and 'has continuant part at all times' some 'material test assessment'
material testing process
endotoxin testing of a representative sample from a buffer lot using a specified assay and evaluation of the resulting endotoxin level against an upper acceptance limit; identity testing of a received media powder lot using infrared spectroscopy and specified chemical reactions and evaluation of the resulting identity evidence against prescribed identity criteria
MaterialTestingProcess(x) → PlannedProcess(x) ∧ ∃m∃r∃p∃t(MaterialEntity(m) ∧ hasInput(x,m) ∧ RequirementSpecification(r) ∧ hasInput(x,r) ∧ MeasurementProcess(p) ∧ hasOccurrentPart(x,p) ∧ MaterialTestingInformationContentEntity(t) ∧ hasSpecifiedOutput(x,t))
planned process that evaluates a material entity or one or more of its attributes against one or more specified testing criteria
if x is a 'material testing process' then x is a 'planned process' that 'has input' some 'material entity', 'has input' some 'requirement specification', 'has occurrent part' some 'measurement process', and 'has specified output' some 'material testing information content entity'
out of specification assessment
an out-of-specification assessment recording that a drug-substance potency result of 91.8% is below the lower acceptance limit of 95.0% specified by the applicable release specification; an out-of-specification assessment recording that a bioburden result of 14 CFU/100 mL exceeds the upper acceptance limit of 10 CFU/100 mL specified for an in-process chromatography pool; an out-of-specification assessment recording that the osmolality of a prepared culture-medium lot exceeds the upper acceptance limit of 320 mOsm/kg; an out-of-specification assessment recording that the infrared spectrum obtained during identity testing of a media powder lot does not meet the specified identity acceptance criterion;
OOS assessment
OOS result
Applicable material conformance specifications may include specifications established in drug applications, drug master files, official compendia, or by the manufacturer, including specifications for in-process laboratory testing.
OutOfSpecificationAssessment(x) → MaterialTestAssessment(x) ∧ ∃a∃s(AcceptanceCriteria(a) ∧ MaterialConformanceSpecification(s) ∧ continuantPartOfAtAllTimes(a,s) ∧ isAbout(x,a))
material test assessment that records that one or more measurement results do not meet the acceptance criteria specified by an applicable material conformance specification
if x is an 'out of specification assessment' then x is a 'material test assessment' that 'is about' some 'acceptance criteria' that are a 'continuant part of at all times' some 'material conformance specification'
spent culture media analysis
measurement of glucose, glutamine, lactate, and ammonia concentrations in clarified spent-culture medium samples collected from a CHO cell culture at specified process times; targeted measurement of amino-acid concentrations in spent-culture medium samples collected before and after a culture-feed addition; LC-MS profiling of extracellular metabolites in spent-culture medium samples collected from reference and perturbed cell-culture runs
1) Spent culture media analysis may use samples taken from culture medium directly or from a cell culture that contains culture medium in a spent culture medium state. In many workflows, the sampled material may initially contain cells, particulates, or other culture-associated material before clarification, centrifugation, filtration, or other sample preparation. 2) Results from spent culture media analysis may be compared with measurements from fresh medium or with measurements obtained at earlier sampling points to evaluate nutrient depletion, metabolite accumulation, or other changes during cell culture.
SpentCultureMediaAnalysis(x) → MeasurementProcess(x) ∧ ∃s (MaterialSample(s) ∧ hasInput(x, s) ∧ ∃p (MaterialSamplingProcess(p) ∧ isSpecifiedOutputOf(s, p) ∧ ∃q(hasPreMaterialState(p, q) ∧ SpentCultureMediumState(q)))))
measurement process in which one or more attributes of material samples containing spent culture medium are measured to characterize the extracellular medium during or following cell culture
if x is a 'spent culture media analysis' then x is a 'measurement process' and x 'has input' some 'material sample' that 'is specified output of' some 'material sampling process' that 'has pre material state' some 'spent culture medium state'