{
  "description": null,
  "_filename": "example/PlanDefinition-cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93.json",
  "package_name": "hl7.fhir.us.pq-cmc-fda",
  "date": "2022-12-08",
  "meta": {
    "profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification" ]
  },
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "approvalDate": "2022-12-08",
  "jurisdiction": [ {
    "coding": [ {
      "code": "US",
      "system": "urn:iso:std:iso:3166",
      "display": "United States of America"
    } ]
  } ],
  "name": null,
  "goal": [ {
    "id": "b304ed45-5295-4082-9827-f20e1ff0d1d3",
    "target": [ {
      "detailCodeableConcept": {
        "text": "Negative",
        "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": "Negative"
    }
  }, {
    "id": "d4e38c52-30f6-4bb7-ab84-99439a7266ce",
    "target": [ {
      "detailCodeableConcept": {
        "text": "Negative",
        "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": "Negative"
    }
  }, {
    "id": "2abf1f19-e1b1-42e4-b943-79f5fa1642fe",
    "target": [ {
      "detailCodeableConcept": {
        "text": "Negative",
        "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": "Negative"
    }
  }, {
    "id": "c0ed4a79-8f40-4d26-8845-4cea166fb627",
    "target": [ {
      "detailQuantity": {
        "code": "C68742",
        "unit": "colony forming units",
        "value": 10,
        "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": "NMT 10 colony-forming units"
    }
  }, {
    "id": "442983b5-bbc3-4534-9f1b-5ae5e4c531c1",
    "target": [ {
      "detailQuantity": {
        "code": "C68742",
        "unit": "colony forming units",
        "value": 100,
        "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": "NMT 100 colony-forming units"
    }
  } ],
  "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 \\\"C134010\\\", :display \\\"Tentatively Approved\\\"}]}",
  "experimental": null,
  "resourceType": "PlanDefinition",
  "title": "Quality Specification for an API",
  "package_version": "1.0.0-ballot",
  "extension": [ {
    "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension",
    "valueCodeableConcept": {
      "coding": [ {
        "code": "C134022",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Drug Substance"
      } ]
    }
  }, {
    "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension",
    "valueMarkdown": "This API is is currently characterized through a standard battery of physicochemical characterzation tests."
  } ],
  "status": "active",
  "id": "af3a0d88-ddee-473a-841b-ce5e2334a044",
  "kind": null,
  "url": "http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93",
  "identifier": [ {
    "value": "ExampleSpecification2"
  }, {
    "value": "urn:oid:2.16.840.1.113883.4.642.40.36.34.6",
    "system": "urn:ietf:rfc:3986"
  } ],
  "action": [ {
    "id": "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
    "code": {
      "text": "Visual",
      "coding": [ {
        "code": "C96102",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
        "display": "Compendial"
      } ]
    },
    "title": "Microbiological Examination of Nonsterile Products",
    "action": [ {
      "title": "Staphylococcus aureus",
      "goalId": [ "b304ed45-5295-4082-9827-f20e1ff0d1d3" ],
      "linkId": "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
      "prefix": "Stage 1",
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
        "valueDecimal": 1
      } ]
    }, {
      "title": "Pseudomonas aeruginosa",
      "goalId": [ "d4e38c52-30f6-4bb7-ab84-99439a7266ce" ],
      "linkId": "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
      "prefix": "Stage 2",
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
        "valueDecimal": 2
      } ]
    }, {
      "title": "Bacillus subtilis",
      "goalId": [ "2abf1f19-e1b1-42e4-b943-79f5fa1642fe" ],
      "linkId": "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
      "prefix": "Stage 3",
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
        "valueDecimal": 3
      } ]
    }, {
      "title": "Total Aerobic Microbial Count (TAMC)",
      "goalId": [ "c0ed4a79-8f40-4d26-8845-4cea166fb627" ],
      "linkId": "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
      "prefix": "Stage 4",
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
        "valueDecimal": 4
      } ]
    }, {
      "title": "Total Yeasts and Molds Count (TYMC)",
      "goalId": [ "442983b5-bbc3-4534-9f1b-5ae5e4c531c1" ],
      "linkId": "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
      "prefix": "Stage 5",
      "extension": [ {
        "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension",
        "valueDecimal": 5
      } ]
    } ],
    "reason": [ {
      "coding": [ {
        "code": "TC13",
        "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes",
        "display": "Microbial Limits"
      } ],
      "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": 1
    } ],
    "documentation": [ {
      "type": "documentation",
      "label": "USP <61>"
    } ]
  } ],
  "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:580c28ac-1a2c-49fa-9be3-de997da5edcf"
  }
}