{
  "description": null,
  "_filename": "example/PlanDefinition-37bf5cc0-33bf-478b-b84e-ccb35143ef6e.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": "e900181a-876c-4ed6-ac96-d5a73c3d6767",
    "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": "21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c",
    "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": "1f476689-f440-4a77-9e9c-0615af3571eb",
    "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": "9c0d2619-4505-4e6b-a801-bc30f84bc3e2",
    "target": [ {
      "detailQuantity": {
        "code": "C48570",
        "unit": "%",
        "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%"
    }
  }, {
    "id": "fc230a97-fd1a-4017-8603-822c5430a217",
    "target": [ {
      "detailQuantity": {
        "code": "C48570",
        "unit": "%",
        "value": 1.5,
        "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": "Formaldehyde NMT 1.5%"
    }
  }, {
    "id": "8d6688e0-7412-4d64-afe8-b73d8aec596e",
    "target": [ {
      "detailQuantity": {
        "code": "C48570",
        "unit": "%",
        "value": 2,
        "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)"
            } ]
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    "addresses": [ {
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        "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": "Impurity C NMT 2%"
    }
  }, {
    "id": "f8e8343d-a37d-4b91-916b-f58d6947dc9c",
    "target": [ {
      "detailQuantity": {
        "code": "C48528",
        "unit": "%{WeightToWeight}",
        "value": 0.1,
        "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": [ {
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        "code": "C134029",
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      } ]
    }, {
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        "display": "Stability"
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    } ],
    "description": {
      "text": "Unspecified Impurity NMT 0.10 % w/w"
    }
  }, {
    "id": "be7abaa1-0769-4560-af76-326e07d1df9a",
    "target": [ {
      "detailQuantity": {
        "code": "C48570",
        "unit": "%",
        "value": 0.7,
        "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": "Total Impurities"
    }
  }, {
    "id": "cfdd469d-020b-4047-946f-f513d58f007f",
    "target": [ {
      "detailQuantity": {
        "code": "C48570",
        "unit": "%",
        "value": 0.3,
        "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"
      } ]
    }, {
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        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "Total Unidentified Impurities NMT 0.3%"
    }
  }, {
    "id": "c5eea380-416f-4d19-a21e-c021f3c7c543",
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      "detailQuantity": {
        "code": "C48528",
        "unit": "%{WeightToWeight}",
        "value": 0.1,
        "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": [ {
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        "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": "RRT 2.2 NMT 0.10% w/w"
    }
  }, {
    "id": "41e19fa2-f568-443e-8bc1-6b0a6dca9d0c",
    "target": [ {
      "detailQuantity": {
        "code": "C48528",
        "unit": "%{WeightToWeight}",
        "value": 0.1,
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
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              "display": "NMT (not more than)"
            } ]
          }
        } ]
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    } ],
    "addresses": [ {
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        "code": "C134029",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
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        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "RRT 2.4 NMT 0.10% w/w"
    }
  }, {
    "id": "e493cb3d-45b6-4463-b9b6-e588c51e032c",
    "target": [ {
      "detailQuantity": {
        "code": "C48528",
        "unit": "%{WeightToWeight}",
        "value": 0.2,
        "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",
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        "display": "Release"
      } ]
    }, {
      "coding": [ {
        "code": "C134030",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Stability"
      } ]
    } ],
    "description": {
      "text": "RRT 3.41 NMT 0.10% w/w"
    }
  } ],
  "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": "Cochineal 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": "61c577d4-a8e8-4887-b5f4-062a65fbfae7",
  "kind": null,
  "url": "http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/37bf5cc0-33bf-478b-b84e-ccb35143ef6e",
  "identifier": [ {
    "value": "CochinealSpecification"
  }, {
    "value": "urn:oid:2.16.840.1.113883.4.642.40.36.34.1",
    "system": "urn:ietf:rfc:3986"
  } ],
  "action": [ {
    "code": {
      "text": "Visual",
      "coding": [ {
        "code": "C96103",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Proprietary"
      } ]
    },
    "title": "Appearance",
    "goalId": [ "e900181a-876c-4ed6-ac96-d5a73c3d6767" ],
    "linkId": "b9359ce8-73f3-45c5-9674-98d850053aa2",
    "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"
    } ]
  }, {
    "code": {
      "text": "FTIR",
      "coding": [ {
        "code": "C96103",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Proprietary"
      } ]
    },
    "title": "Identification",
    "goalId": [ "21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c" ],
    "linkId": "443ed163-7a7b-4d48-9462-be5532158411",
    "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"
    } ]
  }, {
    "code": {
      "text": "Visual",
      "coding": [ {
        "code": "C96103",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Proprietary"
      } ]
    },
    "title": "pH",
    "goalId": [ "1f476689-f440-4a77-9e9c-0615af3571eb" ],
    "linkId": "058193ee-dd86-4c63-9f47-7b0608abbca4",
    "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"
    } ]
  }, {
    "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": [ "9c0d2619-4505-4e6b-a801-bc30f84bc3e2" ],
    "linkId": "940c8db4-9ed1-416e-84ec-9f9e143be8ab",
    "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>"
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