Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
| Active as of 2024-12-04 |
Definitions for the pq-product-batch-ingredient-extension extension.
Guidance on how to interpret the contents of this table can be found here
| 0. Extension | |
| Definition | Extension for measurement properties for ingredients in the batch formla. |
| Short | Product Batch Ingredient Extension |
| 2. Extension.extension | |
| Control | 2..? |
| 4. Extension.extension:overagePercent | |
| Slice Name | overagePercent |
| Control | 1..1 |
| Must Support | true |
| 6. Extension.extension:overagePercent.extension | |
| Control | 0..0 |
| 8. Extension.extension:overagePercent.url | |
| Fixed Value | overagePercent |
| 10. Extension.extension:overagePercent.value[x] | |
| 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. Note: This is not for stability loss, and generally not permitted. Example: 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. |
| Short | Overage Percent |
| Type | decimal |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 12. Extension.extension:overageJustification | |
| Slice Name | overageJustification |
| Control | 1..1 |
| Must Support | true |
| 14. Extension.extension:overageJustification.extension | |
| Control | 0..0 |
| 16. Extension.extension:overageJustification.url | |
| Fixed Value | overageJustification |
| 18. Extension.extension:overageJustification.value[x] | |
| Definition | The rationale for use of excess drug substance during manufacturing of the drug product [Source: SME Defined] |
| Short | Overage Justification |
| Type | markdown |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 20. Extension.url | |
| Fixed Value | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension |
| 22. Extension.value[x] | |
| Control | 0..0 |
Guidance on how to interpret the contents of this table can be found here
| 0. Extension | |
| Definition | Extension for measurement properties for ingredients in the batch formla. Optional Extension Element - found in all resources. |
| Short | Product Batch Ingredient ExtensionOptional Extensions Element |
| Control | 0..* |
| Is Modifier | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 2. Extension.extension | |
| Definition | An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | ExtensionAdditional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 20..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 4. Extension.extension:overagePercent | |
| Slice Name | overagePercent |
| Definition | An Extension |
| Short | ExtensionAdditional content defined by implementations |
| Control | 10..1* |
| Type | Extension |
| Is Modifier | false |
| Must Support | true |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 6. Extension.extension:overagePercent.extension | |
| Definition | An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | ExtensionAdditional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..0* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 8. Extension.extension:overagePercent.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | overagePercent |
| 10. Extension.extension:overagePercent.value[x] | |
| 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. Note: This is not for stability loss, and generally not permitted. Example: 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. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Overage PercentValue of extension |
| Control | 0..1 This element is affected by the following invariants: ext-1 |
| Type | decimal, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 12. Extension.extension:overageJustification | |
| Slice Name | overageJustification |
| Definition | An Extension |
| Short | ExtensionAdditional content defined by implementations |
| Control | 10..1* |
| Type | Extension |
| Is Modifier | false |
| Must Support | true |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 14. Extension.extension:overageJustification.extension | |
| Definition | An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | ExtensionAdditional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..0* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 16. Extension.extension:overageJustification.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | overageJustification |
| 18. Extension.extension:overageJustification.value[x] | |
| Definition | The rationale for use of excess drug substance during manufacturing of the drug product [Source: SME Defined] Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Overage JustificationValue of extension |
| Control | 0..1 This element is affected by the following invariants: ext-1 |
| Type | markdown, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 20. Extension.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension |
| 22. Extension.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..01 This element is affected by the following invariants: ext-1 |
| Type | Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be found here
| 0. Extension | |
| Definition | Extension for measurement properties for ingredients in the batch formla. |
| Short | Product Batch Ingredient Extension |
| Control | 0..* |
| Is Modifier | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2. Extension.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | id |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 4. Extension.extension | |
| Definition | An Extension |
| Short | Extension |
| Control | 2..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 6. Extension.extension:overagePercent | |
| Slice Name | overagePercent |
| Definition | An Extension |
| Short | Extension |
| Control | 1..1 |
| Type | Extension |
| Is Modifier | false |
| Must Support | true |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 8. Extension.extension:overagePercent.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | id |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 10. Extension.extension:overagePercent.extension | |
| Definition | An Extension |
| Short | Extension |
| Control | 0..0 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 12. Extension.extension:overagePercent.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | overagePercent |
| 14. Extension.extension:overagePercent.value[x] | |
| 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. Note: This is not for stability loss, and generally not permitted. Example: 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. |
| Short | Overage Percent |
| Control | 0..1 This element is affected by the following invariants: ext-1 |
| Type | decimal |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 16. Extension.extension:overageJustification | |
| Slice Name | overageJustification |
| Definition | An Extension |
| Short | Extension |
| Control | 1..1 |
| Type | Extension |
| Is Modifier | false |
| Must Support | true |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 18. Extension.extension:overageJustification.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | id |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 20. Extension.extension:overageJustification.extension | |
| Definition | An Extension |
| Short | Extension |
| Control | 0..0 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 22. Extension.extension:overageJustification.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | overageJustification |
| 24. Extension.extension:overageJustification.value[x] | |
| Definition | The rationale for use of excess drug substance during manufacturing of the drug product [Source: SME Defined] |
| Short | Overage Justification |
| Control | 0..1 This element is affected by the following invariants: ext-1 |
| Type | markdown |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 26. Extension.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-ingredient-extension |
| 28. Extension.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..0 This element is affected by the following invariants: ext-1 |
| Type | Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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