Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
resourceType | StructureDefinition |
id | pqcmc-component-substance |
canonical | http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-component-substance |
version | 0.1.15 |
status | draft |
publisher | HL7 International - Biomedical Research and Regulatory WG |
name | ComponentSubstance |
title | Component Substance |
date | 2023-07-17T03:00:13+00:00 |
description | Any raw material intended for use in the manufacture of a drug substance, or any ingredient intended for use in the manufacture of a drug product including those that may not appear in such drug product. |
jurisdictions | us |
fhirVersion | 5.0.0 |
kind | resource |
abstract | false |
sdTtype | SubstanceDefinition |
derivation | constraint |
base | http://hl7.org/fhir/StructureDefinition/SubstanceDefinition |
Usages |
|
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
SubstanceDefinition | C | SubstanceDefinition |
cmc-when-unii-required:
A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acid','Polymer','Protein - Other'. cmc-name-isbt: Name.type ISBT 128 requried for blood products. cmc-source-material: IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable. |
|
meta | ||||
profile | S | ..1 | ||
identifier | ..1 | optional user designated identifier | ||
classification | S | 1.. |
Substance Type Binding: EVMPD Substance Classification ( required ) |
|
grade | 1..1 | Quality Standard | ||
coding | Binding: Quality Standard Terminology ( required ) | |||
manufacturer | S | ..1 | Reference (Manufacturing and/or Test Site Organization) | |
supplier | S | ..1 | Reference (Supplier Organization) | |
structure | S | |||
representation | 1.. | |||
representation | S | |||
format | ||||
coding | Binding: Chemical Structure Data File Type Terminology ( required ) | |||
document | S | Reference (Document Reference Attachment) | Substance Structure Graphic | |
code | S | |||
code | ||||
Slices for coding | Slice: Unordered, Open by pattern:system | |||
coding:unii | 0..1 | UNII | ||
system | 1.. | Required Pattern: https://gsrs.ncats.nih.gov | ||
coding:uniProt | 0..1 | UniProt ID | ||
system | 1.. | Required Pattern: https://www.uniprot.org | ||
Slices for name | S C | 1 .. |
Only one name required
Slice: Unordered, Closed by value:type.coding cmc-name-preferred: Name.preferred: at most one = true |
|
name:All Slices | Content/Rules for all slices | |||
preferred | S | True when the name type is Substance Name | ||
name:sub | S | 0..1 | ||
name | S | Generic | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 138 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: Generic |
|
preferred | S | |||
name:comn | S | 0..1 | ||
name | S | Common | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 139 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: Common |
|
preferred | S | |||
name:gsrs | S | 0..1 | ||
name | S | GSRS Preferred | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 141 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: GSRS Preferred |
|
preferred | S | |||
name:isbt | S | 0..1 | ||
name | S | ISBT 128 | ||
type | S | 1.. | ||
coding | S | 1..1 | Required Pattern: At least the following | |
system | 1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
|
code | 1..1 | code |
Symbol in syntax defined by the system Fixed Value: 226 |
|
display | 1..1 | string |
Representation defined by the system Fixed Value: ISBT 128 |
|
preferred | S | |||
sourceMaterial | S | |||
type | Source Type | |||
coding | Binding: Source Type Terminology ( required ) | |||
genus | S | |||
coding | .. 0 | |||
text | 1.. | Source Organism | ||
species | S | Source Organism | ||
coding | .. 0 | |||
text | 1.. | |||
part | S | Source Organism Part | ||
coding | .. 0 | |||
text | 1.. | |||
countryOfOrigin | S | ..1 | Source Organism Country of Origin | |
coding | S | 1..1 | Binding: GENC Country Codes ( required ) | |
Documentation for this format |
Produced 08 Sep 2023