Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

: Example: Bundle – Product Specification - JSON Representation

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//  Product Specification 
{
  "resourceType" : "Bundle",
  "id" : "bundle-drug-product-specification-pq-ex1",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-specification-pq"
    ]
  },
  "type" : "collection",
  "entry" : [
    {
      "fullUrl" : "urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a",
      "resource" : {
        "resourceType" : "PlanDefinition",
        "id" : "plandefinition-drug-pq-ex3-drug-specification",
        "text" : //  <id value="specificationProtocol"/> 
        // id value="plandefinition-drug-specification-dxpq-ex1"/
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_plandefinition-drug-pq-ex3-drug-specification\"> </a><p><b>Generated Narrative: PlanDefinition</b><a name=\"plandefinition-drug-pq-ex3-drug-specification\"> </a><a name=\"hcplandefinition-drug-pq-ex3-drug-specification\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PlanDefinition &quot;plandefinition-drug-pq-ex3-drug-specification&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a</code></p><p><b>title</b>: SPECIFICATION(S) FOR DRUG PRODUCT</p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5</p><p><b>description</b>: Narrative description of specifications</p><blockquote><p><b>action</b></p><p><b>title</b>: Specification(s) for Drug Product</p><p><b>code</b>: Overall set of actions <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>action</b></p><p><b>title</b>: Release</p><p><b>code</b>: Timing Group <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>timing</b>: Code: Release time</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: End of shelf life</p><p><b>code</b>: Timing Group <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>timing</b>: Code: At end of shelf life</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></div>"
        },
        "url" : "http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a",
        "title" : "SPECIFICATION(S) FOR DRUG PRODUCT",
        "status" : "active",
        "subjectReference" : // <meta>
                    <profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
                </meta>
        // http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a
        {
          "reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
        },
        "description" : "Narrative description of specifications",
        "action" : [
          // MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
          {
            "title" : "Specification(s) for Drug Product",
            "code" : //  this is then entire thing 
            {
              "text" : "Overall set of actions"
            },
            "action" : [
              {
                "title" : "Release",
                "code" : {
                  "text" : "Timing Group"
                },
                "timingTiming" : {
                  "code" : {
                    "text" : "Release time"
                  }
                },
                "action" : [
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c"
                  },
                  // ObservationDefinition/Description
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"
                  },
                  // ObservationDefinition/Identification
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc"
                  },
                  // ObservationDefinition/Assay
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041"
                  },
                  // ObservationDefinition/Degradation
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb"
                  },
                  // ObservationDefinition/Dissolution
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c"
                  },
                  // ObservationDefinition/Uniformity
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71"
                  },
                  // ObservationDefinition/Microbiological
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"
                  }
                ]
              },
              // ObservationDefinition/Water
              {
                "title" : "End of shelf life",
                "code" : {
                  "text" : "Timing Group"
                },
                "timingTiming" : {
                  "code" : {
                    "text" : "At end of shelf life"
                  }
                },
                "action" : [
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec"
                  },
                  // ObservationDefinition/DescriptionEnd
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499"
                  },
                  // ObservationDefinition/IdentificationEnd
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"
                  },
                  // ObservationDefinition/AssayEnd
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f"
                  },
                  // ObservationDefinition/DegradationEnd
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"
                  },
                  // ObservationDefinition/DissolutionEnd
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3"
                  },
                  // ObservationDefinition/UniformityEnd
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e"
                  },
                  // ObservationDefinition/MicrobiologicalEnd
                  {
                    "code" : {
                      "text" : "Test"
                    },
                    "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851"
                  }
                ]
              }
            ]
          }
        ]
      }
    },
    // ObservationDefinition/WaterEnd
    {
      "fullUrl" : "urn:uuid:77e7020a-270c-6bed-2e55-28e9e942546c",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "77e7020a-270c-6bed-2e55-28e9e942546c",
        "text" : // Description
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_77e7020a-270c-6bed-2e55-28e9e942546c\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"77e7020a-270c-6bed-2e55-28e9e942546c\"> </a><a name=\"hc77e7020a-270c-6bed-2e55-28e9e942546c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;77e7020a-270c-6bed-2e55-28e9e942546c&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c</code></p><p><b>title</b>: Description</p><p><b>status</b>: active</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#DESC)</span></p><p><b>method</b>: Visual inspection <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c",
        "title" : "Description",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "DESC",
              "display" : "Description"
            }
          ],
          "text" : "Description"
        },
        "method" : {
          "text" : "Visual inspection"
        },
        "qualifiedValue" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                "valueString" : "An orange film-coated tablet, debossed with 175 on one side"
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:d24ce3cd-213d-4935-97cf-8e2dd03721ec",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "d24ce3cd-213d-4935-97cf-8e2dd03721ec",
        "text" : // DescriptionEnd
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_d24ce3cd-213d-4935-97cf-8e2dd03721ec\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"d24ce3cd-213d-4935-97cf-8e2dd03721ec\"> </a><a name=\"hcd24ce3cd-213d-4935-97cf-8e2dd03721ec\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;d24ce3cd-213d-4935-97cf-8e2dd03721ec&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec</code></p><p><b>title</b>: Description</p><p><b>status</b>: active</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#DESC)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec",
        "title" : "Description",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "DESC",
              "display" : "Description"
            }
          ],
          "text" : "Description"
        },
        "qualifiedValue" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                "valueString" : "As for release"
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:0d0ef4cf-242c-1cb1-81c4-c41837ee9a12",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "0d0ef4cf-242c-1cb1-81c4-c41837ee9a12",
        "text" : // Identification
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_0d0ef4cf-242c-1cb1-81c4-c41837ee9a12\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"0d0ef4cf-242c-1cb1-81c4-c41837ee9a12\"> </a><a name=\"hc0d0ef4cf-242c-1cb1-81c4-c41837ee9a12\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;0d0ef4cf-242c-1cb1-81c4-c41837ee9a12&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#IDT)</span></p><p><b>method</b>: ID by UHPLC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12",
        "title" : "Identification",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "IDT",
              "display" : "Identification"
            }
          ],
          "text" : "Identification"
        },
        "method" : {
          "text" : "ID by UHPLC"
        },
        "qualifiedValue" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                "valueString" : "Consistent with the retention time and UV spectrum of the reference standard"
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:f77ba972-5ef8-a178-9a5f-fe7f54da7499",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "f77ba972-5ef8-a178-9a5f-fe7f54da7499",
        "text" : // IdentificationEnd
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_f77ba972-5ef8-a178-9a5f-fe7f54da7499\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"f77ba972-5ef8-a178-9a5f-fe7f54da7499\"> </a><a name=\"hcf77ba972-5ef8-a178-9a5f-fe7f54da7499\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;f77ba972-5ef8-a178-9a5f-fe7f54da7499&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#IDT)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499",
        "title" : "Identification",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "IDT",
              "display" : "Identification"
            }
          ],
          "text" : "Identification"
        },
        "qualifiedValue" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                "valueString" : "As for release"
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:c0f05343-5b98-6073-1a0f-873aaf4f59bc",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "c0f05343-5b98-6073-1a0f-873aaf4f59bc",
        "text" : // Assay
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_c0f05343-5b98-6073-1a0f-873aaf4f59bc\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"c0f05343-5b98-6073-1a0f-873aaf4f59bc\"> </a><a name=\"hcc0f05343-5b98-6073-1a0f-873aaf4f59bc\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;c0f05343-5b98-6073-1a0f-873aaf4f59bc&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>method</b>: Assay by UHPLC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc",
        "title" : "Assay",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "ASSAY",
              "display" : "Assay"
            }
          ],
          "text" : "Assay"
        },
        "method" : {
          "text" : "Assay by UHPLC"
        },
        "qualifiedValue" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                "valueString" : "95% to 105% of label claim"
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:f4a74fd3-876e-38ce-021f-04e5a8fb6a3f",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "f4a74fd3-876e-38ce-021f-04e5a8fb6a3f",
        "text" : // AssayEnd
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_f4a74fd3-876e-38ce-021f-04e5a8fb6a3f\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"f4a74fd3-876e-38ce-021f-04e5a8fb6a3f\"> </a><a name=\"hcf4a74fd3-876e-38ce-021f-04e5a8fb6a3f\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;f4a74fd3-876e-38ce-021f-04e5a8fb6a3f&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#ASSAY)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f",
        "title" : "Assay",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "ASSAY",
              "display" : "Assay"
            }
          ],
          "text" : "Assay"
        },
        "qualifiedValue" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                "valueString" : "As for release"
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:a3d4d23a-800a-684a-6a47-fcfe44e06041",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "a3d4d23a-800a-684a-6a47-fcfe44e06041",
        "text" : // Degradation
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_a3d4d23a-800a-684a-6a47-fcfe44e06041\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"a3d4d23a-800a-684a-6a47-fcfe44e06041\"> </a><a name=\"hca3d4d23a-800a-684a-6a47-fcfe44e06041\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;a3d4d23a-800a-684a-6a47-fcfe44e06041&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041</code></p><p><b>title</b>: Degradation Products</p><p><b>status</b>: active</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#DGP)</span></p><p><b>method</b>: Degradation products by UHPLC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.2</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.3</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.3</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Individual unspecified degradation products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.2</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total degradation products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-1.4</p></blockquote><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041",
        "title" : "Degradation Products",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "DGP",
              "display" : "Degradation Products"
            }
          ]
        },
        "method" : {
          "text" : "Degradation products by UHPLC"
        },
        "qualifiedValue" : [
          {
            "appliesTo" : [
              {
                "text" : "Impurity 1"
              }
            ],
            "range" : //  could be a code 
            {
              "high" : {
                "value" : 0.2,
                "unit" : "% w/w"
              }
            }
          },
          {
            "appliesTo" : [
              {
                "text" : "Impurity 2"
              }
            ],
            "range" : {
              "high" : {
                "value" : 0.3,
                "unit" : "% w/w"
              }
            }
          },
          {
            "appliesTo" : [
              {
                "text" : "Impurity 3"
              }
            ],
            "range" : {
              "high" : {
                "value" : 0.3,
                "unit" : "% w/w"
              }
            }
          },
          {
            "appliesTo" : [
              {
                "text" : "Individual unspecified degradation products"
              }
            ],
            "range" : {
              "high" : {
                "value" : 0.2,
                "unit" : "% w/w"
              }
            }
          },
          {
            "appliesTo" : [
              {
                "text" : "Total degradation products"
              }
            ],
            "range" : {
              "high" : {
                "value" : 1.4,
                "unit" : "% w/w"
              }
            }
          }
        ],
        "component" : [
          {
            "code" : //  are expected to have a component that says what impurity this one is 
            {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                  "code" : "IMP",
                  "display" : "Impurity"
                }
              ]
            }
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:ef72eeb7-211a-3c16-8460-8725ca43584f",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "ef72eeb7-211a-3c16-8460-8725ca43584f",
        "text" : // DegradationEnd
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_ef72eeb7-211a-3c16-8460-8725ca43584f\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"ef72eeb7-211a-3c16-8460-8725ca43584f\"> </a><a name=\"hcef72eeb7-211a-3c16-8460-8725ca43584f\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;ef72eeb7-211a-3c16-8460-8725ca43584f&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f</code></p><p><b>title</b>: Degradation Products</p><p><b>status</b>: active</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#DGP)</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.8</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.4</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.4</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Individual unspecified degradation products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-2.3</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total degradation products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-2.3</p></blockquote><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f",
        "title" : "Degradation Products",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "DGP",
              "display" : "Degradation Products"
            }
          ]
        },
        "qualifiedValue" : [
          {
            "appliesTo" : [
              {
                "text" : "Impurity 1"
              }
            ],
            "range" : //  could be a code 
            {
              "high" : {
                "value" : 0.8,
                "unit" : "% w/w"
              }
            }
          },
          {
            "appliesTo" : [
              {
                "text" : "Impurity 2"
              }
            ],
            "range" : {
              "high" : {
                "value" : 0.4,
                "unit" : "% w/w"
              }
            }
          },
          {
            "appliesTo" : [
              {
                "text" : "Impurity 3"
              }
            ],
            "range" : {
              "high" : {
                "value" : 0.4,
                "unit" : "% w/w"
              }
            }
          },
          {
            "appliesTo" : [
              {
                "text" : "Individual unspecified degradation products"
              }
            ],
            "range" : {
              "high" : {
                "value" : 2.3,
                "unit" : "% w/w"
              }
            }
          },
          {
            "appliesTo" : [
              {
                "text" : "Total degradation products"
              }
            ],
            "range" : {
              "high" : {
                "value" : 2.3,
                "unit" : "% w/w"
              }
            }
          }
        ],
        "component" : [
          {
            "code" : //  are expected to have a component that says what impurity this one is 
            {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                  "code" : "IMP",
                  "display" : "Impurity"
                }
              ]
            }
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:bb11322b-9470-4f13-91b5-c8a5253380eb",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "bb11322b-9470-4f13-91b5-c8a5253380eb",
        "text" : // Dissolution
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_bb11322b-9470-4f13-91b5-c8a5253380eb\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"bb11322b-9470-4f13-91b5-c8a5253380eb\"> </a><a name=\"hcbb11322b-9470-4f13-91b5-c8a5253380eb\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;bb11322b-9470-4f13-91b5-c8a5253380eb&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb</code></p><p><b>title</b>: Dissolution</p><p><b>status</b>: active</p><p><b>code</b>: Dissolution <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#Dissolution)</span></p><p><b>method</b>: Apparatus 2 (paddles), UV measurement <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb",
        "title" : "Dissolution",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "Dissolution",
              "display" : "Dissolution"
            }
          ],
          "text" : "Dissolution"
        },
        "method" : {
          "text" : "Apparatus 2 (paddles), UV measurement"
        },
        "qualifiedValue" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                "valueString" : "Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes"
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea",
        "text" : // DissolutionEnd
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea\"> </a><a name=\"hc6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea</code></p><p><b>title</b>: Dissolution</p><p><b>status</b>: active</p><p><b>code</b>: Dissolution <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#Dissolution)</span></p><p><b>method</b>: Apparatus 2 (paddles), UV measurement <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea",
        "title" : "Dissolution",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "Dissolution",
              "display" : "Dissolution"
            }
          ],
          "text" : "Dissolution"
        },
        "method" : {
          "text" : "Apparatus 2 (paddles), UV measurement"
        },
        "qualifiedValue" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                "valueString" : "As for release"
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:6ce8ab6d-55e2-0412-5fb1-ab33763f30b1",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "6ce8ab6d-55e2-0412-5fb1-ab33763f30b1",
        "text" : // Water
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_6ce8ab6d-55e2-0412-5fb1-ab33763f30b1\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"6ce8ab6d-55e2-0412-5fb1-ab33763f30b1\"> </a><a name=\"hc6ce8ab6d-55e2-0412-5fb1-ab33763f30b1\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;6ce8ab6d-55e2-0412-5fb1-ab33763f30b1&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1</code></p><p><b>title</b>: Water Content</p><p><b>status</b>: active</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>method</b>: USP &lt;921&gt; <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>?-1.0</td></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1",
        "title" : "Water Content",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "WaterContent",
              "display" : "Water Content"
            }
          ],
          "text" : "Water Content"
        },
        "method" : {
          "text" : "USP <921>"
        },
        "qualifiedValue" : [
          {
            "range" : {
              "high" : {
                "value" : 1.0,
                "unit" : "% w/w"
              }
            }
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:91391017-774b-5c77-93fa-642534278851",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "91391017-774b-5c77-93fa-642534278851",
        "text" : // WaterEnd
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_91391017-774b-5c77-93fa-642534278851\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"91391017-774b-5c77-93fa-642534278851\"> </a><a name=\"hc91391017-774b-5c77-93fa-642534278851\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;91391017-774b-5c77-93fa-642534278851&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851</code></p><p><b>title</b>: Water Content</p><p><b>status</b>: active</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>method</b>: USP &lt;921&gt; <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>?-2.0</td></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851",
        "title" : "Water Content",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "WaterContent",
              "display" : "Water Content"
            }
          ],
          "text" : "Water Content"
        },
        "method" : {
          "text" : "USP <921>"
        },
        "qualifiedValue" : [
          {
            "range" : {
              "high" : {
                "value" : 2.0,
                "unit" : "% w/w"
              }
            }
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:64972eb3-99ee-7eae-2f63-733e5ae84f71",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "64972eb3-99ee-7eae-2f63-733e5ae84f71",
        "text" : // Microbiological
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_64972eb3-99ee-7eae-2f63-733e5ae84f71\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"64972eb3-99ee-7eae-2f63-733e5ae84f71\"> </a><a name=\"hc64972eb3-99ee-7eae-2f63-733e5ae84f71\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;64972eb3-99ee-7eae-2f63-733e5ae84f71&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71</code></p><p><b>title</b>: Microbiological</p><p><b>status</b>: active</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>method</b>: Ph Eur <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71",
        "title" : "Microbiological",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "Microbiological Quality",
              "display" : "Microbiological Quality"
            }
          ],
          "text" : "Microbiological Quality"
        },
        "method" : {
          "text" : "Ph Eur"
        },
        "qualifiedValue" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                "valueString" : "Shall comply with the requirements of the Ph Eur"
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:e582e504-36ec-3b50-4043-51bf1147124e",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "e582e504-36ec-3b50-4043-51bf1147124e",
        "text" : // MicrobiologicalEnd
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_e582e504-36ec-3b50-4043-51bf1147124e\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"e582e504-36ec-3b50-4043-51bf1147124e\"> </a><a name=\"hce582e504-36ec-3b50-4043-51bf1147124e\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;e582e504-36ec-3b50-4043-51bf1147124e&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e</code></p><p><b>title</b>: Microbiological</p><p><b>status</b>: active</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>method</b>: Ph Eur <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e",
        "title" : "Microbiological",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "Microbiological Quality",
              "display" : "Microbiological Quality"
            }
          ],
          "text" : "Microbiological Quality"
        },
        "method" : {
          "text" : "Ph Eur"
        },
        "qualifiedValue" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                "valueString" : "As for release"
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:e7e2fe59-5433-5cc0-84b1-d5f30032790c",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "e7e2fe59-5433-5cc0-84b1-d5f30032790c",
        "text" : // Uniformity
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_e7e2fe59-5433-5cc0-84b1-d5f30032790c\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"e7e2fe59-5433-5cc0-84b1-d5f30032790c\"> </a><a name=\"hce7e2fe59-5433-5cc0-84b1-d5f30032790c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;e7e2fe59-5433-5cc0-84b1-d5f30032790c&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c</code></p><p><b>title</b>: Uniformity of dosage</p><p><b>status</b>: active</p><p><b>code</b>: uniformity of dosage units (by weight) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>method</b>: Weight variation <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c",
        "title" : "Uniformity of dosage",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "uniformity-dosage",
              "display" : "uniformity of dosage units (by weight)"
            }
          ],
          "text" : "uniformity of dosage units (by weight)"
        },
        "method" : {
          "text" : "Weight variation"
        },
        "qualifiedValue" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                "valueString" : "Shall comply with the requirements of the harmonised USP/JP/Ph Eur"
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:43dbc2a3-00c4-6f79-6b11-63768b412aa3",
      "resource" : {
        "resourceType" : "ObservationDefinition",
        "id" : "43dbc2a3-00c4-6f79-6b11-63768b412aa3",
        "text" : // UniformityEnd
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_43dbc2a3-00c4-6f79-6b11-63768b412aa3\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"43dbc2a3-00c4-6f79-6b11-63768b412aa3\"> </a><a name=\"hc43dbc2a3-00c4-6f79-6b11-63768b412aa3\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition &quot;43dbc2a3-00c4-6f79-6b11-63768b412aa3&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3</code></p><p><b>title</b>: Uniformity of dosage</p><p><b>status</b>: active</p><p><b>code</b>: uniformity of dosage units (by weight) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#uniformity-dosage)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
        },
        "url" : "http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3",
        "title" : "Uniformity of dosage",
        "status" : "active",
        "code" : // http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
              "code" : "uniformity-dosage",
              "display" : "uniformity of dosage units (by weight)"
            }
          ],
          "text" : "uniformity of dosage units (by weight)"
        },
        "qualifiedValue" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                "valueString" : "As for release"
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
      "resource" : //  Section 1.1 - DP Identification 
      {
        "resourceType" : "MedicinalProductDefinition",
        "id" : "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
        "text" : // medicinalproductdefinition-drug-product-pq-ex1
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </a><p><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </a><a name=\"hca0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource MedicinalProductDefinition &quot;a0694a7a-aafa-4cbe-8135-c788a9a4d3d5&quot; </p></div><p><b>description</b>: Textual description of the product</p><p><b>combinedPharmaceuticalDoseForm</b>: Gastro-resistant tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#10225000)</span></p><p><b>route</b>: Oral use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#20053000)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Stelbat Tablets, 20mg</p><p><b>type</b>: Proprietary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-productNameType-pq-example.html\">Product Name Type - example</a>#Proprietary)</span></p><h3>Parts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>20mg</td><td>Strength part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-name-part-type.html\">Product Name Part Type</a>#StrengthPart)</span></td></tr></table></blockquote></div>"
        },
        "description" : "Textual description of the product",
        "combinedPharmaceuticalDoseForm" : {
          "coding" : [
            {
              "system" : "http://standardterms.edqm.eu",
              "code" : "10225000",
              "display" : "Gastro-resistant tablet"
            }
          ]
        },
        "route" : [
          {
            "coding" : [
              {
                "system" : "http://standardterms.edqm.eu",
                "code" : "20053000",
                "display" : "Oral use"
              }
            ]
          }
        ],
        "name" : [
          {
            "productName" : "Stelbat Tablets, 20mg",
            "type" : {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example",
                  "code" : "Proprietary",
                  "display" : "Proprietary"
                }
              ]
            },
            "part" : [
              {
                "part" : "20mg",
                "type" : {
                  "coding" : [
                    {
                      "system" : "http://hl7.org/fhir/medicinal-product-name-part-type",
                      "code" : "StrengthPart",
                      "display" : "Strength part"
                    }
                  ]
                }
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6",
      "resource" : {
        "resourceType" : "Ingredient",
        "id" : "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6",
        "text" : // productIngredient
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_a0694a7a-aafa-4cbe-8135-c788a9a4d3d6\"> </a><p><b>Generated Narrative: Ingredient</b><a name=\"a0694a7a-aafa-4cbe-8135-c788a9a4d3d6\"> </a><a name=\"hca0694a7a-aafa-4cbe-8135-c788a9a4d3d6\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Ingredient &quot;a0694a7a-aafa-4cbe-8135-c788a9a4d3d6&quot; </p></div><p><b>status</b>: active</p><p><b>for</b>: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5</p><p><b>role</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072072)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td>See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152</td></tr></table></blockquote></div>"
        },
        "status" : "active",
        "for" : [
          {
            "reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
          }
        ],
        "role" : // MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
        {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/ingredient-role",
              "code" : "100000072072",
              "display" : "Active"
            }
          ]
        },
        "substance" : {
          "code" : {
            "reference" : {
              "reference" : "SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152"
            }
          }
        }
      }
    },
    // SubstanceDefinition/substance1
    {
      "fullUrl" : "urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152",
      "resource" : {
        "resourceType" : "SubstanceDefinition",
        "id" : "c458791f-7cb8-428e-83f7-8a205f821152",
        "text" : // substance1
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_c458791f-7cb8-428e-83f7-8a205f821152\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"c458791f-7cb8-428e-83f7-8a205f821152\"> </a><a name=\"hcc458791f-7cb8-428e-83f7-8a205f821152\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SubstanceDefinition &quot;c458791f-7cb8-428e-83f7-8a205f821152&quot; </p></div><p><b>manufacturer</b>: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d</p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbatolol</td></tr></table></div>"
        },
        "manufacturer" : [
          {
            "reference" : "Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d"
          }
        ],
        "name" : [
          // Organization/substance-manufacturer
          {
            "name" : "Stelbatolol"
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d",
      "resource" : {
        "resourceType" : "Organization",
        "id" : "9fe98cfa-9245-8313-0fc5-d15e613b5d6d",
        "text" : // substance-manufacturer
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_9fe98cfa-9245-8313-0fc5-d15e613b5d6d\"> </a><p><b>Generated Narrative: Organization</b><a name=\"9fe98cfa-9245-8313-0fc5-d15e613b5d6d\"> </a><a name=\"hc9fe98cfa-9245-8313-0fc5-d15e613b5d6d\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization &quot;9fe98cfa-9245-8313-0fc5-d15e613b5d6d&quot; </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3003040516</p><p><b>active</b>: true</p><p><b>type</b>: Drug Substance Manufacture <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pharmaceutical-organization-type.html\">Pharmaceutical Organization Type Codes</a>#drug-substance-manufacture)</span></p><p><b>name</b>: AAA Molybdenum Products, Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>"
        },
        "identifier" : [
          {
            "system" : "urn:oid:2.16.840.1.113883.4.82",
            "value" : "3003040516"
          }
        ],
        "active" : true,
        "type" : [
          //  FDA establishment identifier 
          {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type",
                "code" : "drug-substance-manufacture",
                "display" : "Drug Substance Manufacture"
              }
            ]
          }
        ],
        "name" : "AAA Molybdenum Products, Inc.",
        "contact" : [
          {
            "address" : {
              "line" : [
                "7233 W 116th Pl",
                "Ste C"
              ],
              "city" : "Broomfield",
              "state" : "Colorado",
              "postalCode" : "80020",
              "country" : "USA"
            }
          }
        ]
      }
    }
  ]
}