Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

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 1.1.6 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

ValueSet: PQCMC Product Characteristic

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic Version: 1.1.6
Draft as of 2024-09-22 Computable Name: PqcmcProductCharacteristic
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.16

Product Characteristic for the characteristic element in ManufacturedItemDefinition for product composition.

References

Logical Definition (CLD)

Generated Narrative: ValueSet pqcmc-product-characteristic

 

Expansion

Generated Narrative: ValueSet

Expansion based on codesystem PQ-CMC-FDA Temporary Codes v1.1.6 (CodeSystem)

This value set contains 26 concepts

CodeSystemDisplay
  OvrRelsProfhttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Overall Release Profile
  OvrRelsMechhttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Overall Release Mechanism
  CoatIndhttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyCoating Indicator
  TabLayCnthttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyTablet Layer Count
  BeaTypCnthttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyTablet Bead Type Count
  CapConCnthttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyCapsule Constituent Count
  CapClasshttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyCapsule Classification Category
  Schematichttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Schematic
  WgtTyphttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Weight Type
  TotWgtNumhttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Total Weight Numeric Numerator
  TotWgtDenhttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Total Weight Numeric Denominator
  TotWgtTxthttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyTotal Weight Textual
  TotWgtOperhttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyTotal Weight Operator
  PPiDhttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Part Identifier
  PPiDrefhttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Part Identifier Reference
  RelsProfhttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Part Release Profile
  RelsMechhttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Part Release Mechanism
  CoatPurposehttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyCoating Product Part Purpose
  Colorhttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Part Color Description
  ContPercenthttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Part Content Percent
  AddInfohttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Part Additional Information
  StrnTypehttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyStrength Type (for API)
  AmtOperhttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Part Ingredient Amount Operator
  AmtTexthttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyProduct Part Ingredient Amount Textual
  QualStdhttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummyQuality Standard
  Sterilehttp://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummySterile Product Indicator

Explanation of the columns that may appear on this page:

Level A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies
System The source of the definition of the code (when the value set draws in codes defined elsewhere)
Code The code (used as the code in the resource instance)
Display The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
Definition An explanation of the meaning of the concept
Comments Additional notes about how to use the code