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

• Narrative Content
• XML
• JSON

ValueSet: Quality Benchmark Terminology

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology				Version: 1.1.6
Draft as of 2024-09-22				Computable Name: PqcmcQualityBenchmarkTerminology
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.19

Terminology used to qualify the information pertaining to quality benchmarks in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

References

• Component Substance
• Excipient Drug Substance
• Manufactured Drug Product
• Drug Substance Handle

Logical Definition (CLD)

 

Expansion

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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