Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
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
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-analytical-intstrument-data | Version: 2.0.0-ballot | |||
| Active as of 2024-12-04 | Computable Name: AnalyticalInstrumentData | |||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.55 | ||||
Any attached file that contains analytical instrument data
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from PqcmcAttachment
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Attachment |
PqcmcAttachment | This is an abstractprofile. | ||
 contentType |
1..1 | code | Mime type of the content, with charset etc. Binding: Analytical Instrument Data File Types (required) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Attachment.contentType | required | PqcmcAnalyticalInstrumentDataTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-analytical-instrument-data-typesfrom this IG |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Attachment |
C | 0..* | PqcmcAttachment | This is an abstractprofile. Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType |
  contentType |
SΣC | 1..1 | code | Mime type of the content, with charset etc. Binding: Analytical Instrument Data File Types (required) Example General: text/plain; charset=UTF-8, image/png |
| data |
SC | 1..1 | base64Binary | Data inline, base64ed |
| title |
SΣ | 1..1 | string | Document file name including the file extension Example General: Official Corporate Logo |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Attachment.contentType | required | PqcmcAnalyticalInstrumentDataTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-analytical-instrument-data-typesfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| att-1 | error | Attachment | If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Attachment |
C | 0..* | PqcmcAttachment | This is an abstractprofile. Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
 extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| contentType |
SΣC | 1..1 | code | Mime type of the content, with charset etc. Binding: Analytical Instrument Data File Types (required) Example General: text/plain; charset=UTF-8, image/png | ||||
| language |
Σ | 0..1 | code | Human language of the content (BCP-47) Binding: AllLanguages (required): IETF language tag for a human language.
Example General: en-AU | ||||
| data |
SC | 1..1 | base64Binary | Data inline, base64ed | ||||
| url |
Σ | 0..1 | url | Uri where the data can be found Example General: http://www.acme.com/logo-small.png | ||||
| size |
Σ | 0..1 | integer64 | Number of bytes of content (if url provided) | ||||
| hash |
Σ | 0..1 | base64Binary | Hash of the data (sha-1, base64ed) | ||||
| title |
SΣ | 1..1 | string | Document file name including the file extension Example General: Official Corporate Logo | ||||
| creation |
Σ | 0..1 | dateTime | Date attachment was first created | ||||
| height |
0..1 | positiveInt | Height of the image in pixels (photo/video) | |||||
| width |
0..1 | positiveInt | Width of the image in pixels (photo/video) | |||||
| frames |
0..1 | positiveInt | Number of frames if > 1 (photo) | |||||
| duration |
0..1 | decimal | Length in seconds (audio / video) | |||||
| pages |
0..1 | positiveInt | Number of printed pages | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| Attachment.contentType | required | PqcmcAnalyticalInstrumentDataTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-analytical-instrument-data-typesfrom this IG | |
| Attachment.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| att-1 | error | Attachment | If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from PqcmcAttachment
Differential View
This structure is derived from PqcmcAttachment
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Attachment |
PqcmcAttachment | This is an abstractprofile. | ||
| contentType |
1..1 | code | Mime type of the content, with charset etc. Binding: Analytical Instrument Data File Types (required) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Attachment.contentType | required | PqcmcAnalyticalInstrumentDataTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-analytical-instrument-data-typesfrom this IG |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Attachment |
C | 0..* | PqcmcAttachment | This is an abstractprofile. Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType |
| contentType |
SΣC | 1..1 | code | Mime type of the content, with charset etc. Binding: Analytical Instrument Data File Types (required) Example General: text/plain; charset=UTF-8, image/png |
| data |
SC | 1..1 | base64Binary | Data inline, base64ed |
| title |
SΣ | 1..1 | string | Document file name including the file extension Example General: Official Corporate Logo |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Attachment.contentType | required | PqcmcAnalyticalInstrumentDataTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-analytical-instrument-data-typesfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| att-1 | error | Attachment | If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Attachment |
C | 0..* | PqcmcAttachment | This is an abstractprofile. Content in a format defined elsewhere att-1: If the Attachment has data, it SHALL have a contentType | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| contentType |
SΣC | 1..1 | code | Mime type of the content, with charset etc. Binding: Analytical Instrument Data File Types (required) Example General: text/plain; charset=UTF-8, image/png | ||||
| language |
Σ | 0..1 | code | Human language of the content (BCP-47) Binding: AllLanguages (required): IETF language tag for a human language.
Example General: en-AU | ||||
| data |
SC | 1..1 | base64Binary | Data inline, base64ed | ||||
| url |
Σ | 0..1 | url | Uri where the data can be found Example General: http://www.acme.com/logo-small.png | ||||
| size |
Σ | 0..1 | integer64 | Number of bytes of content (if url provided) | ||||
| hash |
Σ | 0..1 | base64Binary | Hash of the data (sha-1, base64ed) | ||||
| title |
SΣ | 1..1 | string | Document file name including the file extension Example General: Official Corporate Logo | ||||
| creation |
Σ | 0..1 | dateTime | Date attachment was first created | ||||
| height |
0..1 | positiveInt | Height of the image in pixels (photo/video) | |||||
| width |
0..1 | positiveInt | Width of the image in pixels (photo/video) | |||||
| frames |
0..1 | positiveInt | Number of frames if > 1 (photo) | |||||
| duration |
0..1 | decimal | Length in seconds (audio / video) | |||||
| pages |
0..1 | positiveInt | Number of printed pages | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI |
| Attachment.contentType | required | PqcmcAnalyticalInstrumentDataTypeshttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-analytical-instrument-data-typesfrom this IG | |
| Attachment.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| att-1 | error | Attachment | If the Attachment has data, it SHALL have a contentType : data.empty() or contentType.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from PqcmcAttachment
Other representations of profile: CSV, Excel, Schematron
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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