Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
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/pqcmc-product-characteristic | Version: 1.0.0-ballot | |||
| Active as of 2024-04-08 | 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
http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy| Code | Display |
| OvrRelsProf | Product Overall Release Profile |
| OvrRelsMech | Product Overall Release Mechanism |
| CoatInd | Coating Indicator |
| TabLayCnt | Tablet Layer Count |
| BeaTypCnt | Tablet Bead Type Count |
| CapConCnt | Capsule Constituent Count |
| CapClass | Capsule Classification Category |
| Schematic | Product Schematic |
| WgtTyp | Product Weight Type |
| TotWgtNum | Product Total Weight Numeric Numerator |
| TotWgtDen | Product Total Weight Numeric Denominator |
| TotWgtTxt | Total Weight Textual |
| TotWgtOper | Total Weight Operator |
| PPiD | Product Part Identifier |
| PPiDref | Product Part Identifier Reference |
| RelsProf | Product Part Release Profile |
| RelsMech | Product Part Release Mechanism |
| CoatPurpose | Coating Product Part Purpose |
| Color | Product Part Color Description |
| ContPercent | Product Part Content Percent |
| AddInfo | Product Part Additional Information |
| StrnType | Strength Type (for API) |
| AmtOper | Product Part Ingredient Amount Operator |
| AmtText | Product Part Ingredient Amount Textual |
| QualStd | Quality Standard |
Expansion based on codesystem PQ-CMC-FDA Temporary Codes v1.0.0-ballot (CodeSystem)
This value set contains 25 concepts.
| Code | System | Display |
| OvrRelsProf | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Overall Release Profile |
| OvrRelsMech | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Overall Release Mechanism |
| CoatInd | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Coating Indicator |
| TabLayCnt | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Tablet Layer Count |
| BeaTypCnt | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Tablet Bead Type Count |
| CapConCnt | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Capsule Constituent Count |
| CapClass | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Capsule Classification Category |
| Schematic | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Schematic |
| WgtTyp | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Weight Type |
| TotWgtNum | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Total Weight Numeric Numerator |
| TotWgtDen | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Total Weight Numeric Denominator |
| TotWgtTxt | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Total Weight Textual |
| TotWgtOper | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Total Weight Operator |
| PPiD | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Part Identifier |
| PPiDref | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Part Identifier Reference |
| RelsProf | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Part Release Profile |
| RelsMech | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Part Release Mechanism |
| CoatPurpose | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Coating Product Part Purpose |
| Color | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Part Color Description |
| ContPercent | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Part Content Percent |
| AddInfo | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Part Additional Information |
| StrnType | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Strength Type (for API) |
| AmtOper | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Part Ingredient Amount Operator |
| AmtText | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Product Part Ingredient Amount Textual |
| QualStd | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Quality Standard |
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 |
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-08
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