{
  "description": null,
  "_filename": "example/PlanDefinition-a2cba634-a481-4b07-9bd4-62c7ada31e1b.json",
  "package_name": "hl7.fhir.us.pq-cmc-fda",
  "date": "2023-12-01",
  "meta": {
    "profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification" ]
  },
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "jurisdiction": [ {
    "coding": [ {
      "code": "US",
      "system": "urn:iso:std:iso:3166",
      "display": "United States of America"
    } ]
  } ],
  "name": null,
  "goal": [ {
    "id": "9bc2bfdf-c9b1-440a-bafe-89f2674341d4",
    "target": [ {
      "detailCodeableConcept": {
        "text": "White solid",
        "coding": [ {
          "code": "C48793",
          "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "display": "EQ"
        } ]
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "White Solid"
    }
  }, {
    "id": "59e2c94a-d383-4776-9b00-3b97b0741c9a",
    "target": [ {
      "detailCodeableConcept": {
        "text": "IR spectrum conforms to reference standard",
        "coding": [ {
          "code": "C48793",
          "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "display": "EQ"
        } ]
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "IR spectrum conforms to reference standard"
    }
  }, {
    "id": "a2ed2d13-e96a-4d7b-b825-c69afd334cf7",
    "target": [ {
      "detailRange": {
        "low": {
          "code": "C45997",
          "unit": "pH",
          "value": 3.4,
          "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "extension": [ {
            "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
            "valueCodeableConcept": {
              "coding": [ {
                "code": "C61583",
                "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                "display": "NLT (not less than)"
              } ]
            }
          } ]
        },
        "high": {
          "code": "C45997",
          "unit": "pH",
          "value": 4.3,
          "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
          "extension": [ {
            "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
            "valueCodeableConcept": {
              "coding": [ {
                "code": "C61586",
                "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
                "display": "NMT (not more than)"
              } ]
            }
          } ]
        }
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "pH 3.4-4.3"
    }
  }, {
    "id": "e046aab8-b10f-4e13-89e6-bfa869a90b38",
    "target": [ {
      "detailQuantity": {
        "code": "C48570",
        "unit": "percent",
        "value": 0.21,
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "extension": [ {
          "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension",
          "valueCodeableConcept": {
            "coding": [ {
              "code": "C61586",
              "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
              "display": "NMT (not more than)"
            } ]
          }
        } ]
      }
    } ],
    "addresses": [ {
      "coding": [ {
        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "residue <= 0.21%"
    }
  } ],
  "type": "{:coding [{:system \\\"http://terminology.hl7.org/CodeSystem/plan-definition-type\\\", :code \\\"workflow-definition\\\", :display \\\"Workflow Definition\\\"} {:system \\\"http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy\\\", :code \\\"C48660\\\", :display \\\"Not Applicable\\\"}]}",
  "experimental": null,
  "resourceType": "PlanDefinition",
  "title": "Citric acid specification Example",
  "package_version": "1.0.0-ballot",
  "extension": [ {
    "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension",
    "valueCodeableConcept": {
      "coding": [ {
        "code": "C133931",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Raw Materials/Excipients/Intermediates/Reagents"
      } ]
    }
  } ],
  "status": "active",
  "id": "f69951f0-53e4-4e07-bda3-d5232c5b2541",
  "kind": null,
  "url": "http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/a2cba634-a481-4b07-9bd4-62c7ada31e1b",
  "identifier": [ {
    "value": "CitricAcidSpecification"
  }, {
    "value": "urn:oid:2.16.840.1.113883.4.642.40.36.34.3",
    "system": "urn:ietf:rfc:3986"
  } ],
  "action": [ {
    "id": "fdf5e37f-ae97-48c1-9809-33aebff37199",
    "code": {
      "text": "Visual",
      "coding": [ {
        "code": "C96103",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Proprietary"
      } ]
    },
    "title": "Appearance",
    "goalId": [ "9bc2bfdf-c9b1-440a-bafe-89f2674341d4" ],
    "prefix": "Single Stage",
    "reason": [ {
      "coding": [ {
        "code": "TC6",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
        "display": "Organoleptic"
      } ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension",
        "valueInteger": 1
      } ]
    }, {
      "coding": [ {
        "code": "SUBC20",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
        "display": "Description/Appearance"
      } ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension",
        "valueInteger": 2
      } ]
    } ],
    "extension": [ {
      "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
      "valueDecimal": 1
    } ],
    "documentation": [ {
      "type": "documentation",
      "label": "EX-TEST-101"
    } ]
  }, {
    "id": "f6da4e9e-4954-4fd1-a78a-b297fea64a6f",
    "code": {
      "text": "FTIR",
      "coding": [ {
        "code": "C96103",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Proprietary"
      } ]
    },
    "title": "Identification",
    "goalId": [ "59e2c94a-d383-4776-9b00-3b97b0741c9a" ],
    "prefix": "Single Stage",
    "reason": [ {
      "coding": [ {
        "code": "TC7",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
        "display": "Identification"
      } ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension",
        "valueInteger": 1
      } ]
    } ],
    "extension": [ {
      "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
      "valueDecimal": 2
    } ],
    "documentation": [ {
      "type": "documentation",
      "label": "EX-TEST-102"
    } ]
  }, {
    "id": "a5beeff6-dcc1-4b42-8ea1-76dea4b0da1d",
    "code": {
      "text": "Visual",
      "coding": [ {
        "code": "C96103",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Proprietary"
      } ]
    },
    "title": "pH",
    "goalId": [ "a2ed2d13-e96a-4d7b-b825-c69afd334cf7" ],
    "prefix": "Single Stage",
    "reason": [ {
      "coding": [ {
        "code": "TC23",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
        "display": "pH"
      } ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension",
        "valueInteger": 1
      } ]
    } ],
    "extension": [ {
      "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
      "valueDecimal": 3
    } ],
    "documentation": [ {
      "type": "documentation",
      "label": "EX-TEST-103"
    } ]
  }, {
    "id": "aad4c3ce-985d-45ab-9d00-c2c01ca3813f",
    "code": {
      "text": "Visual",
      "coding": [ {
        "code": "C96102",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Compendial"
      } ]
    },
    "title": "Residue on Ignition",
    "goalId": [ "e046aab8-b10f-4e13-89e6-bfa869a90b38" ],
    "prefix": "Single Stage",
    "reason": [ {
      "coding": [ {
        "code": "TC38",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
        "display": "Residue on Ignition"
      } ],
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension",
        "valueInteger": 1
      } ]
    } ],
    "extension": [ {
      "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
      "valueDecimal": 4
    } ],
    "documentation": [ {
      "type": "documentation",
      "label": "USP <281>"
    } ]
  } ],
  "version": "1.0.0-ballot",
  "contact": [ {
    "name": "HL7 International / Biomedical Research and Regulation",
    "telecom": [ {
      "value": "http://www.hl7.org/Special/committees/rcrim",
      "system": "url"
    }, {
      "value": "brr@lists.HL7.org",
      "system": "email"
    } ]
  } ],
  "subjectReference": {
    "reference": "urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a"
  }
}