Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
resourceType | StructureDefinition |
id | pqcmc-excipient |
canonical | http://hl7.org/fhir/us/pq-cmc/StructureDefinition/pqcmc-excipient |
version | 0.1.15 |
status | draft |
publisher | HL7 International - Biomedical Research and Regulatory WG |
name | ExcipientRaw |
title | Excipient Drug Substance |
date | 2023-07-17T03:00:13+00:00 |
description | Provides sufficient information to identify an inactive substance and raw materials and its source when stability data is required in the submission. |
jurisdictions | us |
fhirVersion | 5.0.0 |
kind | resource |
abstract | false |
sdTtype | SubstanceDefinition |
derivation | constraint |
base | http://hl7.org/fhir/StructureDefinition/SubstanceDefinition |
Usages |
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Name | Flags | Card. | Type |
Description & Constraints
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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. |
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S | ..1 | ||
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..1 | optional user designated identifier | ||
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S | 1.. |
Substance Type Binding: EVMPD Substance Classification ( required ) |
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1..1 | Quality Standard | ||
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Binding: Quality Standard Terminology ( required ) | |||
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S | ..1 | Reference (Manufacturing and/or Test Site Organization) | |
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S | ..1 | Reference (Supplier Organization) | |
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S | |||
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Slice: Unordered, Open by pattern:system | |||
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0..1 | UNII | ||
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1.. | Required Pattern: https://gsrs.ncats.nih.gov | ||
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0..1 | UniProt ID | ||
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1.. | Required Pattern: https://www.uniprot.org | ||
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S C | 1 .. |
Only one name required
Slice: Unordered, Closed by value:type.coding cmc-name-preferred: Name.preferred: at most one = true |
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Content/Rules for all slices | |||
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S | True when the name type is Substance Name | ||
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S | 0..1 | ||
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S | Generic | ||
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S | 1.. | ||
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S | 1..1 | Required Pattern: At least the following | |
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1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
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1..1 | code |
Symbol in syntax defined by the system Fixed Value: 138 |
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1..1 | string |
Representation defined by the system Fixed Value: Generic |
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S | |||
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S | 0..1 | ||
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S | Common | ||
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S | 1.. | ||
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S | 1..1 | Required Pattern: At least the following | |
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1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
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1..1 | code |
Symbol in syntax defined by the system Fixed Value: 139 |
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1..1 | string |
Representation defined by the system Fixed Value: Common |
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S | |||
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S | 0..1 | ||
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S | GSRS Preferred | ||
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S | 1.. | ||
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S | 1..1 | Required Pattern: At least the following | |
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1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
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1..1 | code |
Symbol in syntax defined by the system Fixed Value: 141 |
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1..1 | string |
Representation defined by the system Fixed Value: GSRS Preferred |
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S | |||
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S | 0..1 | ||
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S | ISBT 128 | ||
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S | 1.. | ||
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S | 1..1 | Required Pattern: At least the following | |
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1..1 | uri |
Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl |
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1..1 | code |
Symbol in syntax defined by the system Fixed Value: 226 |
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1..1 | string |
Representation defined by the system Fixed Value: ISBT 128 |
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S | |||
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S | |||
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1.. | Source Type | ||
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Binding: Source Type Terminology ( required ) | |||
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S | |||
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.. 0 | |||
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1.. | Source Organism | ||
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S | Source Organism | ||
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.. 0 | |||
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1.. | |||
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S | Source Organism Part | ||
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.. 0 | |||
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1.. | |||
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S | ..1 | Source Organism Country of Origin | |
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S | 1..1 | Binding: GENC Country Codes ( required ) | |
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Produced 08 Sep 2023