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 1.0.0-ballot 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
Mappings for the pqcmc-product-part resource profile.
FinishedProduct |
ManufacturedItemDefinition | Manufactured Item |
identifier | n/a |
status | n/a |
name | n/a |
manufacturedDoseForm | Manufactured Item.Manufactured Dose Form |
unitOfPresentation | Manufactured Item.Unit of Presentation |
manufacturer | Manufactured Item.Manufacturer / Establishment (Organisation) |
marketingStatus | n/a |
ingredient | Manufactured Item.Ingredient (see also FHIR Ingredient resource) |
property | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
property (OvrRelsProf) | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
value[x] (valueCodeableConcept) | Physical Characteristics, attribute's value |
property (OvrRelsMech) | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
value[x] (valueCodeableConcept) | Physical Characteristics, attribute's value |
property (CoatInd) | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
value[x] (valueBoolean) | Physical Characteristics, attribute's value |
property (LayCnt) | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
property (BeaTypCnt) | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
property (CapClass) | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
value[x] (valueCodeableConcept) | Physical Characteristics, attribute's value |
property (CapConCnt) | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
property (Schematic) | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
value[x] (valueAttachment) | Physical Characteristics, attribute's value |
property (WgtTyp) | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
value[x] (valueCodeableConcept) | Physical Characteristics, attribute's value |
property (TotWgtNum) | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
property (TotWgtDen) | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
property (TotWgtTxt) | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
property (TotWgtOper) | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
value[x] (valueCodeableConcept) | Physical Characteristics, attribute's value |
property (QualStd) | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
value[x] (valueCodeableConcept) | Physical Characteristics, attribute's value |
component | Manufactured Item.Physical Characteristics |
type | Physical Characteristics, all attributes |
property | |
property (PPiD) | |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
property (PPiDref) | |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
property (RelsProf) | |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
property (RelsMech) | |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
property (CoatPurpose) | |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
property (Color) | |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
property (ContPercent) | |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
property (AddInfo) | |
type | Physical Characteristics, all attributes |
value[x] | Physical Characteristics, attribute's value |
FinishedProduct |
ManufacturedItemDefinition | Entity, Role, or Act |
meta | |
id | n/a |
extension | n/a |
text | Act.text? |
contained | N/A |
extension | N/A |
modifierExtension | N/A |
manufacturedDoseForm | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
property | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
property (OvrRelsProf) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
value[x] (valueCodeableConcept) | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
property (OvrRelsMech) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
value[x] (valueCodeableConcept) | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
property (CoatInd) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
value[x] (valueBoolean) | |
property (LayCnt) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
id | n/a |
extension | n/a |
value | PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value |
comparator | IVL properties |
unit | PQ.unit |
system | CO.codeSystem, PQ.translation.codeSystem |
code | PQ.code, MO.currency, PQ.translation.code |
property (BeaTypCnt) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
id | n/a |
extension | n/a |
value | PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value |
comparator | IVL properties |
unit | PQ.unit |
system | CO.codeSystem, PQ.translation.codeSystem |
code | PQ.code, MO.currency, PQ.translation.code |
property (CapClass) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
value[x] (valueCodeableConcept) | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
property (CapConCnt) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
id | n/a |
extension | n/a |
value | PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value |
comparator | IVL properties |
unit | PQ.unit |
system | CO.codeSystem, PQ.translation.codeSystem |
code | PQ.code, MO.currency, PQ.translation.code |
property (Schematic) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
value[x] (valueAttachment) | |
property (WgtTyp) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
value[x] (valueCodeableConcept) | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
property (TotWgtNum) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
id | n/a |
extension | n/a |
value | PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value |
comparator | IVL properties |
unit | PQ.unit |
system | CO.codeSystem, PQ.translation.codeSystem |
code | PQ.code, MO.currency, PQ.translation.code |
property (TotWgtDen) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
id | n/a |
extension | n/a |
value | PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value |
comparator | IVL properties |
unit | PQ.unit |
system | CO.codeSystem, PQ.translation.codeSystem |
code | PQ.code, MO.currency, PQ.translation.code |
property (TotWgtTxt) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
property (TotWgtOper) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
property (QualStd) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
component | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
type | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
function | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
amount | |
id | n/a |
extension | n/a |
value | PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value |
comparator | IVL properties |
unit | PQ.unit |
system | CO.codeSystem, PQ.translation.codeSystem |
code | PQ.code, MO.currency, PQ.translation.code |
constituent | |
id | n/a |
modifierExtension | N/A |
amount | |
id | n/a |
extension | n/a |
value | PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value |
comparator | IVL properties |
unit | PQ.unit |
system | CO.codeSystem, PQ.translation.codeSystem |
code | PQ.code, MO.currency, PQ.translation.code |
location | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
function | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
function (Category) | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
function (Function) | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
property | |
property (PPiD) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
property (PPiDref) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
property (RelsProf) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
property (RelsMech) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
property (CoatPurpose) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
property (Color) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
value[x] | |
id | n/a |
extension | n/a |
coding | union(., ./translation) |
text | ./originalText[mediaType/code="text/plain"]/data |
property (ContPercent) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |
property (AddInfo) | |
id | n/a |
extension | n/a |
modifierExtension | N/A |