{ "description": "Extension for measurement properties for ingredients in the batch formla.", "_filename": "StructureDefinition-pq-product-batch-ingredient-extension.json", "package_name": "hl7.fhir.us.pq-cmc-fda", "date": "2024-12-12T19:00:52+00:00", "derivation": "constraint", "publisher": "HL7 International / Biomedical Research and Regulation", "fhirVersion": "5.0.0", "jurisdiction": [ { "coding": [ { "code": "US", "system": "urn:iso:std:iso:3166", "display": "United States of America" } ] } ], "name": "ProductBatchIngredientExtension", "mapping": [ { "uri": "http://hl7.org/v3", "name": "RIM Mapping", "identity": "rim" } ], "abstract": false, "type": "Extension", "experimental": null, "resourceType": "StructureDefinition", "title": "Product Batch Ingredient Extension", "package_version": "2.0.0-ballot", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics", "valueCode": "can-bind" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "brr" } ], "snapshot": { "element": [ { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension", "min": 0, "definition": "Extension for measurement properties for ingredients in the batch formla.", "isModifier": false, "short": "Product Batch Ingredient Extension", "max": "*", "id": "Extension", "base": { "max": "*", "min": 0, "path": "Extension" } }, { "path": "Extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.id", "condition": [ "ele-1" ], "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 2, "definition": "An Extension", "isModifier": false, "short": "Extension", "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "max": "*", "id": "Extension.extension", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 1, "definition": "An Extension", "isModifier": false, "short": "Extension", "type": [ { "code": "Extension" } ], "mustSupport": true, "sliceName": "overagePercent", "max": "1", "id": "Extension.extension:overagePercent", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:overagePercent.id", "condition": [ "ele-1" ], "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "An Extension", "isModifier": false, "short": "Extension", "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "max": "0", "id": "Extension.extension:overagePercent.extension", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "overagePercent", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:overagePercent.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Overage is the percent of a drug substance in excess of the label claim to compensate for the loss, such as manufacturing or other.\nNote: This is not for stability loss, and generally not permitted.\nExample: 3% overage of drug that has a label claim of 10mg of active (API) - the formulation would have 10.3 mg. A batch formula for 100 kg would contain 103 kg of API.", "isModifier": false, "short": "Overage Percent", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "decimal" } ], "max": "1", "id": "Extension.extension:overagePercent.value[x]", "condition": [ "ext-1" ], "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 1, "definition": "An Extension", "isModifier": false, "short": "Extension", "type": [ { "code": "Extension" } ], "mustSupport": true, "sliceName": "overageJustification", "max": "1", "id": "Extension.extension:overageJustification", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:overageJustification.id", "condition": [ "ele-1" ], "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "An Extension", "isModifier": false, "short": "Extension", "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "max": "0", "id": "Extension.extension:overageJustification.extension", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "overageJustification", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:overageJustification.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "The rationale for use of excess drug substance during manufacturing of the drug product [Source: SME Defined]", "isModifier": false, "short": "Overage Justification", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "markdown" } ], "max": "1", "id": "Extension.extension:overageJustification.value[x]", "condition": [ "ext-1" ], "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "path": "Extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list).", "isModifier": false, "short": "Value of extension", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "base64Binary" }, { "code": "boolean" }, { "code": "canonical" }, { "code": "code" }, { "code": "date" }, { "code": "dateTime" }, { "code": "decimal" }, { "code": "id" }, { "code": "instant" }, { "code": "integer" }, { "code": "integer64" }, { "code": "markdown" }, { "code": "oid" }, { "code": "positiveInt" }, { "code": "string" }, { "code": "time" }, { "code": "unsignedInt" }, { "code": "uri" }, { "code": "url" }, { "code": "uuid" }, { "code": "Address" }, { "code": "Age" }, { "code": "Annotation" }, { "code": "Attachment" }, { "code": "CodeableConcept" }, { "code": "CodeableReference" }, { "code": "Coding" }, { "code": "ContactPoint" }, { "code": "Count" }, { "code": "Distance" }, { "code": "Duration" }, { "code": "HumanName" }, { "code": "Identifier" }, { "code": "Money" }, { "code": "Period" }, { "code": "Quantity" }, { "code": "Range" }, { "code": "Ratio" }, { "code": "RatioRange" }, { "code": "Reference" }, { "code": "SampledData" }, { "code": "Signature" }, { "code": "Timing" }, { "code": "ContactDetail" }, { "code": "DataRequirement" }, { "code": "Expression" }, { "code": "ParameterDefinition" }, { "code": "RelatedArtifact" }, { "code": "TriggerDefinition" }, { "code": "UsageContext" }, { "code": "Availability" }, { "code": "ExtendedContactDetail" }, { "code": "Dosage" }, { "code": "Meta" } ], "max": "0", "id": "Extension.value[x]", "condition": [ "ext-1" ], "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false } ] }, "status": "active", "id": "01cbb163-6d4e-4936-b30c-47df32dcbce4", "kind": "complex-type", "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension", "identifier": [ { "value": "urn:oid:2.16.840.1.113883.4.642.40.36.42.41", "system": "urn:ietf:rfc:3986" } ], "context": [ { "type": "element", "expression": "ManufacturedItemDefinition.component.constituent" } ], "version": "2.0.0-ballot", "differential": { "element": [ { "id": "Extension", "path": "Extension", "short": "Product Batch Ingredient Extension", "definition": "Extension for measurement properties for ingredients in the batch formla." }, { "id": "Extension.extension", "min": 2, "path": "Extension.extension" }, { "id": "Extension.extension:overagePercent", "max": "1", "min": 1, "path": "Extension.extension", "sliceName": "overagePercent", "mustSupport": true }, { "id": "Extension.extension:overagePercent.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:overagePercent.url", "path": "Extension.extension.url", "fixedUri": "overagePercent" }, { "id": "Extension.extension:overagePercent.value[x]", "path": "Extension.extension.value[x]", "type": [ { "code": "decimal" } ], "short": "Overage Percent", "definition": "Overage is the percent of a drug substance in excess of the label claim to compensate for the loss, such as manufacturing or other.\nNote: This is not for stability loss, and generally not permitted.\nExample: 3% overage of drug that has a label claim of 10mg of active (API) - the formulation would have 10.3 mg. A batch formula for 100 kg would contain 103 kg of API." }, { "id": "Extension.extension:overageJustification", "max": "1", "min": 1, "path": "Extension.extension", "sliceName": "overageJustification", "mustSupport": true }, { "id": "Extension.extension:overageJustification.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:overageJustification.url", "path": "Extension.extension.url", "fixedUri": "overageJustification" }, { "id": "Extension.extension:overageJustification.value[x]", "path": "Extension.extension.value[x]", "type": [ { "code": "markdown" } ], "short": "Overage Justification", "definition": "The rationale for use of excess drug substance during manufacturing of the drug product [Source: SME Defined]" }, { "id": "Extension.url", "path": "Extension.url", "fixedUri": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension" }, { "id": "Extension.value[x]", "max": "0", "path": "Extension.value[x]" } ] }, "contact": [ { "name": "HL7 International / Biomedical Research and Regulation", "telecom": [ { "value": "http://www.hl7.org/Special/committees/rcrim", "system": "url" }, { "value": "brr@lists.HL7.org", "system": "email" } ] } ], "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension" }