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Packagehl7.fhir.us.pq-cmc-fda
Resource TypeBundle
IdBundle-SpecificationExcipientBundle.json
FHIR VersionR5

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Narrative

No narrative content found in resource


Source1

{
  "resourceType": "Bundle",
  "id": "SpecificationExcipientBundle",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151"
    ]
  },
  "identifier": {
    "system": "urn:ietf:rfc:3986",
    "value": "urn:uuid:813b4312-8b6d-42cc-9b8c-8bb6463388cc"
  },
  "type": "document",
  "timestamp": "2024-01-01T19:42:35.255Z",
  "entry": [
    {
      "fullUrl": "urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4",
      "resource": {
        "resourceType": "Composition",
        "id": "4bd1ed57-852b-42be-a9b0-355f8a2aa7d4",
        "meta": {
          "profile": [
            "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151"
          ]
        },
        "text": {
          "status": "generated",
          "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_4bd1ed57-852b-42be-a9b0-355f8a2aa7d4\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition 4bd1ed57-852b-42be-a9b0-355f8a2aa7d4</b></p><a name=\"4bd1ed57-852b-42be-a9b0-355f8a2aa7d4\"> </a><a name=\"hc4bd1ed57-852b-42be-a9b0-355f8a2aa7d4\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ectd-composition-sp4151.html\">eCTD Specification</a></p></div><p><b>identifier</b>: CochinealSpecificationComposition</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.p.4}\">m3.2.p.4 control of excipients</span></p><p><b>date</b>: 2024-01-01 19:42:35+0000</p><p><b>author</b>: <a href=\"Bundle-BatchFormulaBundle.html#urn-uuid-4f3e9af1-306b-4fad-bf04-7881400b266a\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></p><p><b>title</b>: Cochineal specification Composition Example</p></div>"
        },
        "identifier": [
          {
            "value": "CochinealSpecificationComposition"
          }
        ],
        "status": "final",
        "type": {
          "coding": [
            {
              "system": "http://terminology.hl7.org/CodeSystem/ICHContextOfUse",
              "code": "ich_3.2.p.4",
              "display": "m3.2.p.4 control of excipients"
            }
          ]
        },
        "date": "2024-01-01T19:42:35.254Z",
        "author": [
          {
            "reference": "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"
          }
        ],
        "title": "Cochineal specification Composition Example",
        "section": [
          {
            "title": "32P40",
            "entry": [
              {
                "reference": "urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e"
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl": "urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e",
      "resource": {
        "resourceType": "PlanDefinition",
        "id": "37bf5cc0-33bf-478b-b84e-ccb35143ef6e",
        "meta": {
          "profile": [
            "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"
          ]
        },
        "text": {
          "status": "extensions",
          "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_37bf5cc0-33bf-478b-b84e-ccb35143ef6e\"> </a>\n<div>\n    <table class=\"grid dict\">\n        \n        <tr>\n            <th scope=\"row\"><b>Id: </b></th>\n            <td style=\"padding-left: 4px;\">37bf5cc0-33bf-478b-b84e-ccb35143ef6e</td>\n        </tr>\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Version: </b></th>\n            <td style=\"padding-left: 4px;\">1.0</td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\">\n                <b>\n                    \n                        \n                    \n                </b>\n            </th>\n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <span>CochinealSpecification</span>\n                </p>\n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Title: </b></th>\n            <td style=\"padding-left: 4px;\">Cochineal specification Example</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Type: </b></th>\n            <td style=\"padding-left: 4px;\">\n                \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"http://terminology.hl7.org/6.4.0/CodeSystem-plan-definition-type.html\">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>workflow-definition</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Workflow Definition</span>\n                        </p>\n                        \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>C133931</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Raw Materials/Excipients/Intermediates/Reagents</span>\n                        </p>\n                        \n                    \n                \n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Subject: </b></th>\n            \n            \n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <b>reference: </b> <span>urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf</span>\n                </p>\n                \n                \n                \n            </td>\n            \n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Date: </b></th>\n            <td style=\"padding-left: 4px;\">2023-12-01</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Actions: </b></th>\n            <td style=\"padding-left: 4px;\">\n                <table class=\"grid-dict\">\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Appearance:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Identification:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage pH:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Residue on Ignition:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Impurities:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            <b>Then:</b>\n                            <table class=\"grid-dict\">\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Unidentified Impurities:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        <b>Then:</b> <i>Additional sub-actions not displayed</i>\n                                        \n                                    </td>\n                                </tr>\n                                \n                            </table>\n                            \n                        </td>\n                    </tr>\n                    \n                </table>\n            </td>\n        </tr>\n        \n    </table>\n</div>\n</div>"
        },
        "extension": [
          {
            "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension",
            "valueCodeableConcept": {
              "coding": [
                {
                  "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                  "code": "C48660",
                  "display": "Not Applicable"
                }
              ]
            }
          }
        ],
        "identifier": [
          {
            "value": "CochinealSpecification"
          }
        ],
        "version": "1.0",
        "title": "Cochineal specification Example",
        "type": {
          "coding": [
            {
              "system": "http://terminology.hl7.org/CodeSystem/plan-definition-type",
              "code": "workflow-definition",
              "display": "Workflow Definition"
            },
            {
              "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code": "C133931",
              "display": "Raw Materials/Excipients/Intermediates/Reagents"
            }
          ]
        },
        "status": "active",
        "subjectReference": {
          "reference": "urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf"
        },
        "date": "2023-12-01",
        "goal": [
          {
            "id": "e900181a-876c-4ed6-ac96-d5a73c3d6767",
            "description": {
              "text": "White Solid"
            },
            "addresses": [
              {
                "coding": [
                  {
                    "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code": "C134029",
                    "display": "Release"
                  }
                ]
              },
              {
                "coding": [
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                    "code": "C134030",
                    "display": "Stability"
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                ]
              }
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            "target": [
              {
                "detailString": "White solid"
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          },
          {
            "id": "21c69fab-2cb3-46dc-8c56-d1c64d5ddf5c",
            "description": {
              "text": "IR spectrum conforms to reference standard"
            },
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              {
                "coding": [
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                "detailString": "IR spectrum conforms to reference standard"
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            "description": {
              "text": "pH 3.4-4.3"
            },
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              {
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                          "comparator": ">=",
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                          "value": 4.3,
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        },
        "text": {
          "status": "generated",
          "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 278736ef-2ddf-49e4-895c-3a9f34db36cf</b></p><a name=\"278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><a name=\"hc278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a></p></div><p><b>identifier</b>: Cochineal</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134009}\">Company Standard</span></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov TZ8Z31B35M}\">TZ8Z31B35M</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>Cochineal</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Genus</b></td><td><b>Species</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td><td><span title=\"Codes:\">Dactylopius</span></td><td><span title=\"Codes:\">cochineal</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 TUR}\">Turkey</span></td></tr></table></div>"
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        "text": {
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          "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a</b></p><a name=\"4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><a name=\"hc4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Wunderwerke</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>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>"
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        "name": "Wunderwerke",
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              "line": [
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}