Pharmaceutical Quality (Industry)
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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 Batch Information - JSON Representation

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{
  "resourceType" : "Bundle",
  "id" : "bundle-drug-product-batch-info-pq-ex1",
  "meta" : //  Product Batch Info 
  {
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-batch-info-pq"
    ]
  },
  "type" : "collection",
  "entry" : [
    //  Section 8 - Batch or Lot Information (batch 1 of 3) 
    {
      "fullUrl" : "urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51",
      "resource" : {
        "resourceType" : "Medication",
        "id" : "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51",
        "text" : // medication-actual-batch
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\"> </a><p><b>Generated Narrative: Medication</b><a name=\"339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\"> </a><a name=\"hc339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\"> </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 Medication &quot;339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51&quot; </p></div><p><b>code</b>:  <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Batches</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style=\"display: none\">*</td><td>, , , , </td><td>33445</td></tr></table></div>"
        },
        "code" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq",
              "valueReference" : {
                "reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
              }
            }
          ]
        },
        "batch" : //  todo consider change this be the MID? 
        // MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
              "extension" : [
                {
                  "url" : "manufacturingDate",
                  "valueDateTime" : "2020-06"
                },
                {
                  "url" : "batchQuantity",
                  "valueQuantity" : {
                    "value" : 100100,
                    "unit" : "tablets"
                  }
                },
                {
                  "url" : "batchUtilization",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                        "code" : "C185328",
                        "display" : "Stability Study"
                      }
                    ],
                    "text" : "PPQ / Stability"
                  }
                },
                {
                  "url" : "assignedManufacturer",
                  "valueReference" : {
                    "reference" : "Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"
                  }
                },
                // Organization/manufacturer
                {
                  "url" : "container",
                  "extension" : [
                    {
                      "url" : "closureSystemDescription",
                      "valueString" : "100 cc HDPE Bottle 2 g desiccant"
                    }
                  ]
                }
              ]
            },
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
              "valueDateTime" : "2019-09-08"
            },
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
              "valueQuantity" : {
                "value" : 4.8,
                "unit" : "kg"
              }
            },
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq",
              "valueDateTime" : "2020-08"
            },
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq",
              "valueReference" : {
                "reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"
              }
            }
          ],
          "lotNumber" : "33445"
        }
      }
    },
    // Organization/packaging
    //  local extensions 
    {
      "fullUrl" : "urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc",
      "resource" : {
        "resourceType" : "Medication",
        "id" : "a9dfda53-734b-045f-7ae4-94a6281d53bc",
        "text" : // medication-actual-batch-2
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\"> </a><p><b>Generated Narrative: Medication</b><a name=\"a9dfda53-734b-045f-7ae4-94a6281d53bc\"> </a><a name=\"hca9dfda53-734b-045f-7ae4-94a6281d53bc\"> </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 Medication &quot;a9dfda53-734b-045f-7ae4-94a6281d53bc&quot; </p></div><p><b>code</b>:  <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Batches</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style=\"display: none\">*</td><td>, , , , </td><td>33446</td></tr></table></div>"
        },
        "code" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq",
              "valueReference" : {
                "reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
              }
            }
          ]
        },
        "batch" : // MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
              "extension" : [
                {
                  "url" : "manufacturingDate",
                  "valueDateTime" : "2020-06"
                },
                {
                  "url" : "batchQuantity",
                  "valueQuantity" : {
                    "value" : 100050,
                    "unit" : "tablets"
                  }
                },
                {
                  "url" : "batchUtilization",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                        "code" : "C185328",
                        "display" : "Stability Study"
                      }
                    ],
                    "text" : "PPQ / Stability"
                  }
                },
                {
                  "url" : "assignedManufacturer",
                  "valueReference" : {
                    "reference" : "Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"
                  }
                },
                // Organization/manufacturer
                {
                  "url" : "container",
                  "extension" : [
                    {
                      "url" : "closureSystemDescription",
                      "valueString" : "100 cc HDPE Bottle 2 g desiccant"
                    }
                  ]
                }
              ]
            },
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
              "valueQuantity" : {
                "value" : 4.8,
                "unit" : "kg"
              }
            },
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
              "valueDateTime" : "2019-09-08"
            },
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq",
              "valueDateTime" : "2020-08"
            },
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq",
              "valueReference" : {
                "reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"
              }
            }
          ],
          "lotNumber" : "33446"
        }
      }
    },
    // Organization/packaging
    //  local extensions 
    {
      "fullUrl" : "urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06",
      "resource" : {
        "resourceType" : "Medication",
        "id" : "c6f5fadd-62e6-3a01-93d9-b3b182f67d06",
        "text" : // medication-actual-batch-3
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\"> </a><p><b>Generated Narrative: Medication</b><a name=\"c6f5fadd-62e6-3a01-93d9-b3b182f67d06\"> </a><a name=\"hcc6f5fadd-62e6-3a01-93d9-b3b182f67d06\"> </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 Medication &quot;c6f5fadd-62e6-3a01-93d9-b3b182f67d06&quot; </p></div><p><b>code</b>:  <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Batches</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style=\"display: none\">*</td><td>, , , , </td><td>33447</td></tr></table></div>"
        },
        "code" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq",
              "valueReference" : {
                "reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
              }
            }
          ]
        },
        "batch" : // MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
              "extension" : [
                {
                  "url" : "manufacturingDate",
                  "valueDateTime" : "2020-06"
                },
                {
                  "url" : "batchQuantity",
                  "valueQuantity" : {
                    "value" : 100125,
                    "unit" : "tablets"
                  }
                },
                {
                  "url" : "batchUtilization",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                        "code" : "C185328",
                        "display" : "Stability Study"
                      }
                    ],
                    "text" : "PPQ / Stability"
                  }
                },
                {
                  "url" : "assignedManufacturer",
                  "valueReference" : {
                    "reference" : "Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"
                  }
                },
                // Organization/manufacturer
                {
                  "url" : "container",
                  "extension" : [
                    {
                      "url" : "closureSystemDescription",
                      "valueString" : "100 cc HDPE Bottle 2 g desiccant"
                    }
                  ]
                }
              ]
            },
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
              "valueDateTime" : "2019-09-08"
            },
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq",
              "valueDateTime" : "2020-08"
            },
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq",
              "valueReference" : {
                "reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"
              }
            },
            // Organization/packaging
            {
              "url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
              "valueQuantity" : {
                "value" : 4.8,
                "unit" : "kg"
              }
            }
          ],
          "lotNumber" : "33447"
        }
      }
    },
    //  local extensions 
    {
      "fullUrl" : "urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a",
      "resource" : {
        "resourceType" : "Organization",
        "id" : "0102bca4-46c1-a6bf-1025-cd403fee710a",
        "text" : // manufacturer
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_0102bca4-46c1-a6bf-1025-cd403fee710a\"> </a><p><b>Generated Narrative: Organization</b><a name=\"0102bca4-46c1-a6bf-1025-cd403fee710a\"> </a><a name=\"hc0102bca4-46c1-a6bf-1025-cd403fee710a\"> </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;0102bca4-46c1-a6bf-1025-cd403fee710a&quot; </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3010027650</p><p><b>active</b>: true</p><p><b>type</b>: Drug Product Manufacture <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pharmaceutical-organization-type.html\">Pharmaceutical Organization Type Codes</a>#drug-product-manufacture)</span></p><p><b>name</b>: AAA Pharmaceutical, 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>681 Main Street Lumberton New Jersey 08048 USA </td></tr></table></div>"
        },
        "identifier" : [
          {
            "system" : "urn:oid:2.16.840.1.113883.4.82",
            "value" : "3010027650"
          }
        ],
        "active" : true,
        "type" : [
          //  FDA establishment identifier 
          {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type",
                "code" : "drug-product-manufacture",
                "display" : "Drug Product Manufacture"
              }
            ]
          }
        ],
        "name" : "AAA Pharmaceutical, Inc.",
        "contact" : [
          {
            "address" : {
              "line" : [
                "681 Main Street"
              ],
              "city" : "Lumberton",
              "state" : "New Jersey",
              "postalCode" : "08048",
              "country" : "USA"
            }
          }
        ]
      }
    },
    {
      "fullUrl" : "urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07",
      "resource" : {
        "resourceType" : "Organization",
        "id" : "378fbe5f-5926-3a5c-4c64-5428df877b07",
        "text" : // packaging
        {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_378fbe5f-5926-3a5c-4c64-5428df877b07\"> </a><p><b>Generated Narrative: Organization</b><a name=\"378fbe5f-5926-3a5c-4c64-5428df877b07\"> </a><a name=\"hc378fbe5f-5926-3a5c-4c64-5428df877b07\"> </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;378fbe5f-5926-3a5c-4c64-5428df877b07&quot; </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3008816891</p><p><b>active</b>: true</p><p><b>type</b>: Packaging <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pharmaceutical-organization-type.html\">Pharmaceutical Organization Type Codes</a>#packaging)</span></p><p><b>name</b>: MySite</p></div>"
        },
        "identifier" : [
          {
            "system" : "urn:oid:2.16.840.1.113883.4.82",
            "value" : "3008816891"
          }
        ],
        "active" : true,
        "type" : [
          {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type",
                "code" : "packaging",
                "display" : "Packaging"
              }
            ]
          }
        ],
        "name" : "MySite"
      }
    },
    {
      "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-dxpq-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"
                    }
                  ]
                }
              }
            ]
          }
        ]
      }
    }
  ]
}