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
Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs | Version: 1.1.6 | |||
Draft as of 2024-09-22 | Computable Name: CmcCompSectionTypesVS | |||
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.2 |
Value set of all codes in Code system PQCMC Comp Section Types for bindings that require a value set instead of the code system.
References
Generated Narrative: ValueSet cmc-comp-section-types-vs
http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types
Generated Narrative: ValueSet
Expansion based on codesystem Code System PQCMC Comp Section Types v1.1.6 (CodeSystem)
This value set contains 68 concepts
Code | System | Display |
32S10 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance General Information |
32S11 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Nomenclature |
32S12 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Structure |
32S13 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance General Properties |
32S20 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Manufacture |
32S21 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Manufacturers |
32S22 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Description of Manufacturing Process and Process Controls |
32S23 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Control of Materials |
32S231 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Raw Material Specification |
32S24 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Controls of Critical Steps and Intermediates |
32S25 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Process Validation and/or Evaluation |
32S26 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Manufacturing Process Development |
32S3 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Characterisation |
32S31 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Elucidation of Structure and other Characteristics |
32S32 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Impurities |
32S40 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Control of Drug Substance |
32S41 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Specification |
32S42 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Analytical Procedures |
32S43 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Validation of Analytical Procedures |
32S44 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Batch Analyses |
32S45 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Justification of Specification |
32S50 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Reference Standards or Materials |
32S60 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Container Closure System |
32S70 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Stability |
32S71 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Stability Summary and Conclusions |
32S72 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Postapproval Stability Protocol and Stability Commitment |
32S73 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Stability Data |
32P10 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Description and Composition of the Drug Product |
32P11 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Description |
32P12 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Composition |
32P13 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Container Closure Description |
32P20 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Pharmaceutical Development |
32P21 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Components of the Drug Product |
32P22 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Drug Product |
32P23 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Manufacturing Process Development |
32P24 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Container Closure System |
32P25 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Microbiological Attributes |
32P26 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Compatibility |
32P30 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Manufacture |
32P31 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Manufacturers |
32P32 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Batch Formula |
32P33 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Description of Manufacturing Process and Process Controls |
32P34 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Controls of Critical Steps and Intermediates |
32P35 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Process Validation and/or Evaluation |
32P40 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Control of Excipients |
32P41 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Excipients Specification |
32P42 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Analytical Procedures |
32P43 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Validation of Analytical Procedures |
32P44 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Justification of Specifications |
32P45 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Excipients of Human or Animal Origin |
32P46 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Novel Excipients |
32P50 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product name dosage form |
32P51 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Specification |
32P52 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Analytical Procedures |
32P53 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Validation of Analytical Procedures |
32P54 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Batch Analyses |
32P55 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Characterisation of Impurities |
32P56 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Justification of Specifications |
32P60 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Reference Standards or Materials |
32P70 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Container Closure System |
32P80 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Stability |
32P81 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Stability Summary and Conclusion |
32P82 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Postapproval Stability Protocol and Stability Commitment |
32P83 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Product Stability Data |
SP4151 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Quality Specification |
SP4454 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Batch Analyses |
SP7383 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Stability Data |
SP7181 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Stability Summary and Conclusion |
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 |