This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. The current version which supersedes this version is 2.0.0. For a full list of available versions, see the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs | Version: 1.0.0-ballot | |||
| Active as of 2024-04-08 | 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
http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types
Expansion based on codesystem Code System PQCMC Comp Section Types v1.0.0-ballot (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 |
| 32S30 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types | Substance Characterization |
| 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 Characterization 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 |