Pharmaceutical Quality (Industry)
1.0.0 - STU1

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 – Analytical Procedure, substance - JSON Representation

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    //  Substance Analytical Procedure
    {
      "resourceType" : "Bundle",
      "id" : "bundle-analytical-procedure-pq-ex2-sub",
      "meta" : //    <id value="substance-analytical-procedure"/>
      {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq"
        ]
      },
      "type" : "collection",
      "entry" : [
        {
          "fullUrl" : "urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763f",
          "resource" : {
            "resourceType" : "PlanDefinition",
            "id" : "analyticalProcedure",
            "text" : {
              "status" : "extensions",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_analyticalProcedure\"> </a><p><b>Generated Narrative: PlanDefinition</b><a name=\"analyticalProcedure\"> </a><a name=\"hcanalyticalProcedure\"> </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;analyticalProcedure&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f</code></p><p><b>title</b>: Analytical Procedure</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-pharmaceutical-plan-type.html\">Pharmaceutical Plan Type Codes</a>#analytical-procedure &quot;Analytical Procedure&quot;)</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152</p><blockquote><p><b>action</b></p><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Optical properties <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-process-parameter.html\">Process Parameter Codes</a>#OPTICAL)</span></p><blockquote><p><b>url</b></p><code>valueText</code></blockquote><p><b>value</b>: Same as for blue light</p></blockquote><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Theory <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-process-parameter.html\">Process Parameter Codes</a>#THEORY)</span></p><blockquote><p><b>url</b></p><code>valueText</code></blockquote><p><b>value</b>: MIE</p></blockquote><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Stir Time <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-process-parameter.html\">Process Parameter Codes</a>#STIR)</span></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 1 minute</p></blockquote><p><b>title</b>: Determination of Particle Size of Stelbat by Laser Diffraction (G1112)</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Dispersant</span></p><p><b>role</b>: Dispersant <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-participant-role.html\">Manufacturing Participant Role Codes</a>#dispersant)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Resulting material</span></p><p><b>role</b>: Resulting Material <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-participant-role.html\">Manufacturing Participant Role Codes</a>#ResultingMaterial)</span></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Preparation</p><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Analysis</p><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Calculation</p><p><b>description</b>: The particle size result is calculated automatically by the instrument software for each sample.</p><p><b>code</b>: Calculation <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Reporting</p><p><b>description</b>: Report the average value as per specification</p><p><b>code</b>: Reporting <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></blockquote></div>"
            },
            "url" : "http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f",
            "title" : "Analytical Procedure",
            "type" : // http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f
            {
              "coding" : [
                {
                  "system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
                  "code" : "workflow-definition",
                  "display" : "Workflow Definition"
                },
                {
                  "system" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type",
                  "code" : "analytical-procedure",
                  "display" : "Analytical Procedure"
                }
              ]
            },
            "status" : "active",
            "subjectReference" : {
              "reference" : "SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152"
            },
            "action" : [
              // SubstanceDefinition/substance1
              {
                "extension" : [
                  {
                    "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq",
                    "extension" : [
                      {
                        "url" : "parameter",
                        "valueCodeableConcept" : {
                          "coding" : [
                            {
                              "system" : "http://terminology.hl7.org/CodeSystem/process-parameter",
                              "code" : "OPTICAL",
                              "display" : "Optical properties"
                            }
                          ]
                        }
                      },
                      {
                        "url" : "valueText",
                        "valueString" : "Same as for blue light"
                      }
                    ]
                  },
                  {
                    "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq",
                    "extension" : [
                      {
                        "url" : "parameter",
                        "valueCodeableConcept" : {
                          "coding" : [
                            {
                              "system" : "http://terminology.hl7.org/CodeSystem/process-parameter",
                              "code" : "THEORY",
                              "display" : "Theory"
                            }
                          ]
                        }
                      },
                      {
                        "url" : "valueText",
                        "valueString" : "MIE"
                      }
                    ]
                  },
                  {
                    "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq",
                    "extension" : [
                      {
                        "url" : "parameter",
                        "valueCodeableConcept" : {
                          "coding" : [
                            {
                              "system" : "http://terminology.hl7.org/CodeSystem/process-parameter",
                              "code" : "STIR",
                              "display" : "Stir Time"
                            }
                          ]
                        }
                      },
                      {
                        "url" : "value",
                        "valueQuantity" : //  todo ucum
                        {
                          "value" : 1,
                          "unit" : "minute"
                        }
                      }
                    ]
                  }
                ],
                "title" : "Determination of Particle Size of Stelbat by Laser Diffraction (G1112)",
                "participant" : [
                  //  can have device here or as ObsDef.device
                  {
                    "typeReference" : {
                      "extension" : [
                        {
                          "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq",
                          "valueReference" : {
                            "reference" : "SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8135565f82"
                          }
                        }
                      ],
                      "display" : "Dispersant"
                    },
                    "role" : // SubstanceDefinition/dispersant
                    {
                      "coding" : [
                        {
                          "system" : "http://terminology.hl7.org/CodeSystem/manufacturing-participant-role",
                          "code" : "dispersant",
                          "display" : "Dispersant"
                        }
                      ]
                    }
                  },
                  {
                    "typeReference" : {
                      "extension" : [
                        {
                          "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq",
                          "valueReference" : {
                            "reference" : "SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8035565f82"
                          }
                        }
                      ],
                      "display" : "Resulting material"
                    },
                    "role" : // SubstanceDefinition/resultingMaterial
                    {
                      "coding" : [
                        {
                          "system" : "http://terminology.hl7.org/CodeSystem/manufacturing-participant-role",
                          "code" : "ResultingMaterial",
                          "display" : "Resulting Material"
                        }
                      ]
                    }
                  }
                ],
                "action" : [
                  {
                    "title" : "Sample Preparation",
                    "action" : [
                      {
                        "title" : "Instructions",
                        "description" : "Vortex approximately 30 seconds. Mix briefly by vortexing immediately before use."
                      }
                    ]
                  },
                  {
                    "title" : "Sample Analysis",
                    "action" : [
                      {
                        "code" : {
                          "text" : "Test"
                        },
                        "definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"
                      }
                    ]
                  },
                  // ObservationDefinition/ParticleSize
                  {
                    "title" : "Sample Calculation",
                    "description" : "The particle size result is calculated automatically by the instrument software for each sample.",
                    "code" : {
                      "text" : "Calculation"
                    }
                  },
                  {
                    "title" : "Reporting",
                    "description" : "Report the average value as per specification",
                    "code" : {
                      "text" : "Reporting"
                    }
                  }
                ]
              }
            ]
          }
        },
        {
          "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><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>"
            },
            "name" : [
              {
                "name" : "Stelbatolol"
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8135565f82",
          "resource" : {
            "resourceType" : "SubstanceDefinition",
            "id" : "9f69ec9c-5fd1-30d2-0790-9e8135565f82",
            "text" : // dispersant
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_9f69ec9c-5fd1-30d2-0790-9e8135565f82\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"9f69ec9c-5fd1-30d2-0790-9e8135565f82\"> </a><a name=\"hc9f69ec9c-5fd1-30d2-0790-9e8135565f82\"> </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;9f69ec9c-5fd1-30d2-0790-9e8135565f82&quot; </p></div><h3>Properties</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Shelf life <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>Refer to local laboratory expiration date (may be extended with supporting data) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table><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>0.1% Sorbitan monooleate (Span 80) in hexanes (m/v)</td></tr></table></div>"
            },
            "property" : [
              {
                "type" : {
                  "text" : "Shelf life"
                },
                "valueCodeableConcept" : {
                  "text" : "Refer to local laboratory expiration date (may be extended with supporting data)"
                }
              }
            ],
            "name" : [
              {
                "name" : "0.1% Sorbitan monooleate (Span 80) in hexanes (m/v)"
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82",
          "resource" : {
            "resourceType" : "SubstanceDefinition",
            "id" : "9f69ec9c-5fd1-30d2-0790-9e8035565f82",
            "text" : // resultingMaterial
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_9f69ec9c-5fd1-30d2-0790-9e8035565f82\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"9f69ec9c-5fd1-30d2-0790-9e8035565f82\"> </a><a name=\"hc9f69ec9c-5fd1-30d2-0790-9e8035565f82\"> </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;9f69ec9c-5fd1-30d2-0790-9e8035565f82&quot; </p></div><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>Stelbat in dispersant (approximately 10 mg/mL)</td></tr></table></div>"
            },
            "name" : [
              {
                "name" : "Stelbat in dispersant (approximately 10 mg/mL)"
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e",
          "resource" : {
            "resourceType" : "ObservationDefinition",
            "id" : "12e7e672-40a6-4136-3c1f-b8ba6a7d046e",
            "text" : // ParticleSize
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_12e7e672-40a6-4136-3c1f-b8ba6a7d046e\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4136-3c1f-b8ba6a7d046e\"> </a><a name=\"hc12e7e672-40a6-4136-3c1f-b8ba6a7d046e\"> </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;12e7e672-40a6-4136-3c1f-b8ba6a7d046e&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Particle Size</p><p><b>status</b>: active</p><p><b>description</b>: Number of Analyses: 1 replicate for each sample preparation</p><p><b>code</b>:  <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>specimen</b>: See on this page: SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2</p><p><b>device</b>: See on this page: DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9495c</p><p><b>hasMember</b>: </p><ul><li>See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e</li><li>See on this page: ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e</li><li>See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e</li></ul></div>"
            },
            "url" : "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e",
            "title" : "Particle Size",
            "status" : "active",
            "description" : "Number of Analyses: 1 replicate for each sample preparation",
            "code" : // http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/data-absent-reason",
                  "valueCode" : "unsupported"
                }
              ]
            },
            "specimen" : [
              {
                "reference" : "SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"
              }
            ],
            "device" : [
              // SpecimenDefinition/specimendefinition
              {
                "reference" : "DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9495c"
              }
            ],
            "hasMember" : [
              // DeviceDefinition/laser
              {
                "reference" : "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"
              },
              // ObservationDefinition/ParticleSizeObscuration
              {
                "reference" : "ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e"
              },
              // ObservationDefinition/ParticleRI
              {
                "reference" : "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e"
              }
            ]
          }
        },
        // ObservationDefinition/ParticleSizeRSD
        {
          "fullUrl" : "urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e",
          "resource" : {
            "resourceType" : "ObservationDefinition",
            "id" : "12e7e672-40a6-4036-3c1f-b8ba6a7d045e",
            "text" : // ParticleSizeObscuration
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d045e\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4036-3c1f-b8ba6a7d045e\"> </a><a name=\"hc12e7e672-40a6-4036-3c1f-b8ba6a7d045e\"> </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;12e7e672-40a6-4036-3c1f-b8ba6a7d045e&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e</code></p><p><b>title</b>: Obscuration</p><p><b>status</b>: active</p><p><b>code</b>: Obscuration (%) <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>#Obscuration &quot;Obscuration&quot;)</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>10-30 %</td></tr></table></div>"
            },
            "url" : "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e",
            "title" : "Obscuration",
            "status" : "active",
            "code" : // http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e
            {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                  "code" : "Obscuration",
                  "display" : "Obscuration"
                }
              ],
              "text" : "Obscuration (%)"
            },
            "qualifiedValue" : [
              {
                "range" : {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq",
                      "valueQuantity" : {
                        "value" : 15,
                        "unit" : "%"
                      }
                    }
                  ],
                  "low" : {
                    "value" : 10,
                    "unit" : "%"
                  },
                  "high" : {
                    "value" : 30,
                    "unit" : "%"
                  }
                }
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:12e7e672-41a6-4036-3c1f-b8ba6a7d045e",
          "resource" : {
            "resourceType" : "ObservationDefinition",
            "id" : "12e7e672-41a6-4036-3c1f-b8ba6a7d045e",
            "text" : // ParticleRI
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_12e7e672-41a6-4036-3c1f-b8ba6a7d045e\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-41a6-4036-3c1f-b8ba6a7d045e\"> </a><a name=\"hc12e7e672-41a6-4036-3c1f-b8ba6a7d045e\"> </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;12e7e672-41a6-4036-3c1f-b8ba6a7d045e&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e</code></p><p><b>title</b>: Particle refractive index</p><p><b>status</b>: active</p><p><b>code</b>: Particle refractive index <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>#Refractive index &quot;Refractive index&quot;)</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>1.75-1.75</td></tr></table></div>"
            },
            "url" : "http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e",
            "title" : "Particle refractive index",
            "status" : "active",
            "code" : // http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e
            {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                  "code" : "Refractive index",
                  "display" : "Refractive index"
                }
              ],
              "text" : "Particle refractive index"
            },
            "qualifiedValue" : [
              {
                "range" : {
                  "low" : //  unitless
                  {
                    "value" : 1.75
                  },
                  "high" : //  unitless
                  {
                    "value" : 1.75
                  }
                }
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e",
          "resource" : {
            "resourceType" : "ObservationDefinition",
            "id" : "12e7e672-40a6-4036-3c1f-b8ba6a7d046e",
            "text" : // ParticleSizeRSD
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d046e\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4036-3c1f-b8ba6a7d046e\"> </a><a name=\"hc12e7e672-40a6-4036-3c1f-b8ba6a7d046e\"> </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;12e7e672-40a6-4036-3c1f-b8ba6a7d046e&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Particle Size RSD</p><p><b>status</b>: active</p><p><b>code</b>: Particle Size RSD <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>#Particle Size RSD)</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/12e7e672-40a6-4036-3c1f-b8ba6a7d046e",
            "title" : "Particle Size RSD",
            "status" : "active",
            "code" : // http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e
            {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
                  "code" : "Particle Size RSD",
                  "display" : "Particle Size RSD"
                }
              ],
              "text" : "Particle Size RSD"
            },
            "qualifiedValue" : [
              {
                "extension" : [
                  {
                    "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
                    "valueString" : "The %RSD for the D(v, 0.9) must be not more than 15%"
                  }
                ]
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2",
          "resource" : {
            "resourceType" : "SpecimenDefinition",
            "id" : "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2",
            "text" : // specimendefinition
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SpecimenDefinition_3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\"> </a><p><b>Generated Narrative: SpecimenDefinition</b><a name=\"3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\"> </a><a name=\"hc3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\"> </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 SpecimenDefinition &quot;3a0cde98-4a73-6d67-1dfc-08e3fc9646a2&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2</code></p><p><b>status</b>: active</p><p><b>description</b>: Number of Preparations: 3</p></div>"
            },
            "url" : "http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2",
            "status" : "active",
            "description" : "Number of Preparations: 3"
          }
        },
        // http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2
        {
          "fullUrl" : "urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9495c",
          "resource" : {
            "resourceType" : "DeviceDefinition",
            "id" : "82a39a18-91cf-a19d-76c1-a9e8bad9495c",
            "text" : // laser
            {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"DeviceDefinition_82a39a18-91cf-a19d-76c1-a9e8bad9495c\"> </a><p><b>Generated Narrative: DeviceDefinition</b><a name=\"82a39a18-91cf-a19d-76c1-a9e8bad9495c\"> </a><a name=\"hc82a39a18-91cf-a19d-76c1-a9e8bad9495c\"> </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 DeviceDefinition &quot;82a39a18-91cf-a19d-76c1-a9e8bad9495c&quot; </p></div><p><b>description</b>: Analyzer with disperser and temperature control accessory, or equivalent</p><h3>Classifications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Particle Size Analyzer with Laser Diffraction <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
            },
            "description" : "Analyzer with disperser and temperature control accessory, or equivalent",
            "classification" : [
              {
                "type" : {
                  "text" : "Particle Size Analyzer with Laser Diffraction"
                }
              }
            ]
          }
        }
      ]
    }