| POCP_HD090100UV01 A_SubstanceSpecification |
(Link to Excel View) Derived from RMIM: POCP_RM090100UV01 |
||||||||
| SubstanceSpecification |
Design Comments: A more detailed specification of a substance. A substance specification includes the mode of production, quality standards, and many more details. These details, once defined, may be invoked simply by providing the substance specification code. This implements the IDMP "specified substance". |
||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassRoot, root= "ACT"} |
|||||||||
| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodDefinition, root= "DEF"} |
|||||||||
| code [1..1] (M) Act (CD) {CNE:D:SubstanceSpecification} |
Design Comments: A code for the details of the substance specification provided. If only the code is specified and none of the details it is a short-hand reference to those details specified elsewhere. |
||||||||
| author [0..*] (Author) |
Design Comments: The organization authoring to the substance specification. |
||||||||
| component [0..*] (Component) |
Design Comments: The substance may be specified in detail by analytic observations and by process steps. |
||||||||
| subjectOf [0..*] (Subject) | |||||||||
| Author |
Design Comments: The organization authoring to the substance specification. |
||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
Design Comments: Fixed to AUT. |
||||||||
| assignedEntity [1..1] (R_ProductEstablishmentUniversal) | |||||||||
| Component |
Design Comments: The substance may be specified in detail by analytic observations and by process steps. |
||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
|||||||||
| substanceSpecificationComponent [1..1] (SubstanceSpecificationComponent) | |||||||||
| SubstanceSpecificationComponent | |||||||||
| choice of ProcessStep |
Design Comments: A process step in the production of the substance. |
||||||||
| or Observation |
Design Comments: An analytic observation measuring, for example, an impurity or a quality standard reference ingredient of a complex mixture such as an allergenic extract. |
||||||||
| ProcessStep |
Design Comments: A process step in the production of the substance. |
||||||||
| classCode [1..1] (M) Procedure (CS) {CNE:V:ActClassProcedure, root= "PROC"} |
|||||||||
| moodCode [1..1] (M) Procedure (CS) {CNE:V:ActMoodDefinition, root= "DEF"} |
|||||||||
| code [0..1] Procedure (CD) {CWE:D:ManufacturerActivityActType} |
Design Comments: The code specifying the nature of the process step. |
||||||||
| text [0..1] Procedure (ED) |
|||||||||
| effectiveTime [0..1] Procedure (IVL<TS>) |
|||||||||
| methodCode [0..1] Procedure (CD) {CWE:D:ProcedureMethod} |
Design Comments: Further specification of the process method that adds required specificity which the Act code does not already specify. |
||||||||
| device [0..*] (Device) |
Design Comments: The device (e.g., reactor) used for the performance of the process step. Links to a potentially individually identified device. |
||||||||
| primaryPerformer [0..*] (PrimaryPerformer) |
Design Comments: The performer of a process step, e.g., an establishment manufacturing an ingredient used by many other products. |
||||||||
| participation [0..*] (Interactor) |
Design Comments: A substance use for a process step as a substrate or reagent or catalyst. |
||||||||
| controlVariable [0..*] (ControlVariable) |
Design Comments: Links a derivation process to a control condition under which a derivation process is operated, e.g., to the temperature of the reactor. |
||||||||
| component [0..*] (Component2) | |||||||||
| subjectOf [0..*] (Subject) |
Design Comments: A link between a substance specification and a documentarions or characteristic about it. |
||||||||
| Device |
Design Comments: The device (e.g., reactor) used for the performance of the process step. Links to a potentially individually identified device. |
||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationTargetDevice, root= "DEV"} |
|||||||||
| instanceOfKind [1..1] (R_ProductReportableUniversal) | |||||||||
| PrimaryPerformer |
Design Comments: The performer of a process step, e.g., an establishment manufacturing an ingredient used by many other products. |
||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationPrimaryPerformer, root= "PPRF"} |
|||||||||
| assignedEntity [1..1] (R_ProductEstablishmentUniversal) | |||||||||
| Interactor |
Design Comments: A substance use for a process step as a substrate or reagent or catalyst. |
||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ReactionParticipant} |
Design Comments: Reaction participant can be CSM (input substrate), PRD (output substrate), and CAT (catalyst). For an antigen-antibody reaction, both are considered input substrates (and the antigen antibody complexes would be output substrates.) |
||||||||
| functionCode [0..1] Participation (CD) {CWE:D:MolecularInteractionFunction} |
Design Comments: Specifies in detail the role of the substance in the process step. |
||||||||
| quantity [0..1] Participation (PQ) |
Design Comments: Specifies, if relevant, the amount of the substance interacting in the interaction. |
||||||||
| substanceRole [1..1] (R_SubstanceUniversal) | |||||||||
| ControlVariable |
Design Comments: Links a derivation process to a control condition under which a derivation process is operated, e.g., to the temperature of the reactor. |
||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasControlVariable, root= "CTRLV"} |
Design Comments: Fixed to CTRLV. |
||||||||
| characteristic [1..1] (A_CharacteristicUniversal) | |||||||||
| Component2 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
|||||||||
| sequenceNumber [0..1] ActRelationship (INT.NONNEG) |
|||||||||
| processStep [1..1] (ProcessStep) | |||||||||
| Subject |
Design Comments: A link between a substance specification and a documentarions or characteristic about it. |
||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasSubject, root= "SUBJ"} |
Design Comments: Fixed to SUBJ (subject) |
||||||||
| information [1..1] (Information) | |||||||||
| Information | |||||||||
| choice of A_ReferencedDocumentUniversal | |||||||||
| or A_CharacteristicUniversal | |||||||||
| Observation |
Design Comments: An analytic observation measuring, for example, an impurity or a quality standard reference ingredient of a complex mixture such as an allergenic extract. |
||||||||
| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassObservation, root= "OBS"} |
|||||||||
| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodDefinition, root= "DEF"} |
|||||||||
| id [0..*] Observation (DSET<II>) |
|||||||||
| code [0..1] Observation (CD) {CWE:D:ObservationType} |
Design Comments: The property measured in the analysis. |
||||||||
| text [0..1] Observation (ED) |
|||||||||
| value [0..1] Observation (ANY) {CWE:D:ObservationValue} |
|||||||||
| analyte [0..1] (Analyte) |
Design Comments: The analyte substance measured by the analytic observation. |
||||||||
| subjectOf [0..*] (Subject) | |||||||||
| Analyte |
Design Comments: The analyte substance measured by the analytic observation. |
||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAnalyte, root= "ALY"} |
|||||||||
| substanceRole [1..1] (R_SubstanceUniversal) | |||||||||