{ "description": null, "_filename": "example/PlanDefinition-aa514363-d43f-4052-b44e-b67aa4d6dee7.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", "jurisdiction": [ { "coding": [ { "code": "US", "system": "urn:iso:std:iso:3166", "display": "United States of America" } ] } ], "name": null, "goal": [ { "id": "32649771-1290-4386-9cf7-7a72274f22b4", "target": [ { "detailRange": { "low": { "code": "C45997", "unit": "pH", "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": "C61583", "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy", "display": "NLT (not less than)" } ] } } ] }, 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} ] } } ], "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": "Maxima only at the same wavelengths compared to reference standard" } }, { "id": "c40aa176-e6aa-4fe4-869d-6550ee992903", "target": [ { "detailQuantity": { "code": "C48570", "unit": "percent", "value": 0.5, "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": 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"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": "<= 0.05 %" } }, { "id": "8d7c85c2-7a4b-432e-ac94-226f296e4fca", "target": [ { "detailCodeableConcept": { "text": "pass", "coding": [ { "code": "C48793", "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy", "display": "EQ" } ] } } ], "addresses": [ { "coding": [ { "code": "C134029", "system": 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"http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy", "display": "Stability" } ] } ], "description": { "text": "<= 0.014 %" } }, { "id": "b46dce64-a009-46cd-ab95-21d1d5b4df77", "target": [ { "detailQuantity": { "code": "C48570", "unit": "percent", "value": 0.04, "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": "<= 0.04 %" } }, { "id": "5566f501-37e1-49fb-8783-b20c074ec0c3", "target": [ { "detailQuantity": { "code": "C48570", "unit": "percent", "value": 0.001, "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": "<= 0.001 %" } }, { "id": "db19e3ab-e28b-4477-8bd7-2409093ed5a3", "target": [ { "detailCodeableConcept": { "text": "pass", "coding": [ { "code": "C48793", "system": 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"display": "LT (less 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": "Ethanol < 0.2%" } }, { "id": "cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2", "target": [ { "measure": { "text": "Ethyl Ether" }, "detailQuantity": { "code": "C48570", "unit": "percent", "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": "C61585", "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy", "display": "LT (less than)" } ] } } ] } } ], "addresses": [ { "coding": [ { "code": "C134029", "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy", "display": "Release" } ] } ], "description": { "text": "Ethyl Ether < 0.1%" } }, { "id": "28ad4d5b-d975-4f6e-9792-b3d9cc7ce279", "target": [ { "measure": { "text": "1—propanol" }, "detailQuantity": { "code": "C48570", "unit": "percent", "value": 0.15, "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": "C61585", "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy", "display": "LT (less than)" } ] } } ] } } ], "addresses": [ { "coding": [ { "code": "C134029", "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy", "display": "Release" } ] } ], "description": { "text": "1—propanol < 0.15%" } }, { "id": "33fa051c-6b3c-4e4d-bd4e-09d39fc253b3", "target": [ { "measure": { "text": "Total Residual Solvents" }, "detailQuantity": { "code": "C48570", "unit": "percent", "value": 0.5, "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": "C61585", "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy", "display": "LT (less than)" } ] } } ] } } ], "addresses": [ { "coding": [ { "code": "C134029", "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy", "display": "Release" } ] } ], "description": { "text": "Total < 0.5%" } }, { "id": "9100e938-42ff-4004-8473-ed5090d66f3a", "target": [ { "detailRange": { "low": { "code": "C48570", "unit": "percent", "value": 99.5, "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": "C61583", "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy", "display": "NLT (not less than)" } ] } } ] }, "high": { "code": "C48570", "unit": "percent", "value": 100.5, "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": "99.5 - 100.5 %" } }, { "id": "af260128-f105-4692-ba40-49f21f12ad46", "target": [ { "detailInteger": 6 } ], "addresses": [ { "coding": [ { "code": "C134029", "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy", "display": "Release" } ] } ], "description": { "text": "n=6" } }, { "id": "31d9dcac-bf72-420b-a415-c924155a83f4", "target": [ { "detailQuantity": { "code": "C48570", "unit": "percent", "value": 85, "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)" } ] } } ] } } ], "addresses": [ { "coding": [ { "code": "C134029", "system": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy", "display": "Release" } ] } ], "description": { "text": "Each unit is NLT Q + 5%" } }, { "id": "47c0d685-0b23-4637-9af8-a554e4fad7ec", "target": [ { "detailInteger": 6 } ], "addresses": [ { 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