Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 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

## Data Type Profile: Analysis Graphic ( Abstract )

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-attachment | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | Computable Name: GraphicAttachment
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.56

Any attached file that contains a graphical representation

Usages:

- Use this DataType Profile: Drug Substance Impurity, Drug Substance, Graphic Reference and Manufactured Drug Product

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Attachment | C | 0..* | PqcmcAttachment | This is an abstract profile. Content in a format defined elsewhere Constraints: att-1
contentType | S Σ C | 1..1 | code | Mime type of the content, with charset etc. Binding: Graphical File Types (required) Example General: text/plain; charset=UTF-8, image/png
data | S C | 1..1 | base64Binary | Data inline, base64ed
title | S Σ | 1..1 | string | Document file name including the file extension Example General: Official Corporate Logo
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Attachment.contentType | required | PqcmcGraphicalFileTypes `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-graphical-file-types` From this IG

#### Constraints

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()) |

This structure is derived from PqcmcAttachment

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Attachment |  |  | PqcmcAttachment | This is an abstract profile.
contentType |  | 1..1 | code | Mime type of the content, with charset etc. Binding: Graphical File Types (required)
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
Attachment.contentType | required | PqcmcGraphicalFileTypes `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-graphical-file-types` From this IG

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Attachment | C | 0..* | PqcmcAttachment | This is an abstract profile. Content in a format defined elsewhere Constraints: att-1
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 | S Σ C | 1..1 | code | Mime type of the content, with charset etc. Binding: Graphical 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.
Additional Bindings | Purpose
CommonLanguages | Starter
Example General: en-AU
data | S C | 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 | S Σ | 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

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Attachment.contentType | required | PqcmcGraphicalFileTypes `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-graphical-file-types` From this IG
Attachment.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard

#### Constraints

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

Summary

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Attachment | C | 0..* | PqcmcAttachment | This is an abstract profile. Content in a format defined elsewhere Constraints: att-1
contentType | S Σ C | 1..1 | code | Mime type of the content, with charset etc. Binding: Graphical File Types (required) Example General: text/plain; charset=UTF-8, image/png
data | S C | 1..1 | base64Binary | Data inline, base64ed
title | S Σ | 1..1 | string | Document file name including the file extension Example General: Official Corporate Logo
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Attachment.contentType | required | PqcmcGraphicalFileTypes `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-graphical-file-types` From this IG

#### Constraints

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()) |

Differential View

This structure is derived from PqcmcAttachment

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Attachment |  |  | PqcmcAttachment | This is an abstract profile.
contentType |  | 1..1 | code | Mime type of the content, with charset etc. Binding: Graphical File Types (required)
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
Attachment.contentType | required | PqcmcGraphicalFileTypes `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-graphical-file-types` From this IG

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Attachment | C | 0..* | PqcmcAttachment | This is an abstract profile. Content in a format defined elsewhere Constraints: att-1
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 | S Σ C | 1..1 | code | Mime type of the content, with charset etc. Binding: Graphical 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.
Additional Bindings | Purpose
CommonLanguages | Starter
Example General: en-AU
data | S C | 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 | S Σ | 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

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Attachment.contentType | required | PqcmcGraphicalFileTypes `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-graphical-file-types` From this IG
Attachment.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard

#### Constraints

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

Summary

Maturity: 2

Other representations of profile: CSV, Excel, Schematron