{
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      "author" : [{
        "reference" : "urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519"
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      "title" : "Control of Materials Example",
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    "fullUrl" : "urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a",
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      "id" : "cd84a8b5-4e96-551c-15c6-c97c943eb38a",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_cd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition cd84a8b5-4e96-551c-15c6-c97c943eb38a</b></p><a name=\"cd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </a><a name=\"hccd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </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-routine-drug-substance.html\">Drug Substance Handle</a></p></div><p><b>identifier</b>: salicylate</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 C134006}\">USP-NF</span></p><p><b>manufacturer</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></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 R16CO5Y76E}\">R16CO5Y76E</span></td></tr></table><blockquote><p><b>name</b></p><p><b>name</b>: ACETYLSALICYLIC ACID</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C97054}\">Generic Name</span></p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: ASPIRIN</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></p><p><b>preferred</b>: true</p></blockquote></div>"
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          "code" : "C48807",
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      "grade" : [{
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          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C134006",
          "display" : "USP-NF"
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      "manufacturer" : [{
        "reference" : "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
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      "code" : [{
        "code" : {
          "coding" : [{
            "system" : "http://fdasis.nlm.nih.gov",
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      "name" : [{
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          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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      {
        "name" : "ASPIRIN",
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          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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            "display" : "GSRS Preferred Term"
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        "preferred" : true
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  {
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      "id" : "4b565cf3-5353-48af-8cd6-5ccf4e9fd579",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579</b></p><a name=\"4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </a><a name=\"hc4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </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/783452221, FEI/6913973</p><p><b>name</b>: Manufacturing Site (J. Jones Research)</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>Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States</td></tr></table></div>"
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          "coding" : [{
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      {
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        "value" : "6913973"
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      "name" : "Manufacturing Site (J. Jones Research)",
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          "type" : "postal",
          "text" : "Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States",
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  {
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      "id" : "e99bddfa-c1b5-435b-bbe8-24816b4e23e5",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization e99bddfa-c1b5-435b-bbe8-24816b4e23e5</b></p><a name=\"e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><a name=\"hce99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </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, FEI/6981397</p><p><b>name</b>: Vidinaid</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>Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA</td></tr></table></div>"
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        "system" : "urn:oid:2.16.840.1.113883.4.82",
        "value" : "6981397"
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      "name" : "Vidinaid",
      "contact" : [{
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          "type" : "postal",
          "text" : "Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA",
          "line" : ["100 Stillwater Avenue",
          "Building #2"],
          "city" : "Bangor",
          "state" : "ME",
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          "country" : "USA"
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  {
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      "meta" : {
        "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</b></p><a name=\"d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><a name=\"hcd9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </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/173265332</p><p><b>name</b>: Mega Chem Supply</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>Mega Chem Supply, 350 W Main Street, Rochester, NY, United States</td></tr></table></div>"
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      "name" : "Mega Chem Supply",
      "contact" : [{
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          "text" : "Mega Chem Supply, 350 W Main Street, Rochester, NY, United States",
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          "postalCode" : "14608",
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  {
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      "id" : "0efb1188-04f0-44ba-bfe7-ca6169ca8703",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"]
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      "text" : {
        "status" : "generated",
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      "classification" : [{
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          "display" : "Structurally Diverse Substance"
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      "grade" : [{
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      "manufacturer" : [{
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        "code" : {
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      "name" : [{
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        "type" : {
          "coding" : [{
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            "display" : "GSRS Preferred Term"
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        "preferred" : true
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      "sourceMaterial" : {
        "type" : {
          "coding" : [{
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            "code" : "C14258",
            "display" : "Plant"
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        },
        "genus" : {
          "text" : "palmaria"
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        "species" : {
          "text" : "palmata"
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        "part" : {
          "text" : "whole"
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        "countryOfOrigin" : [{
          "coding" : [{
            "system" : "urn:iso:std:iso:3166",
            "code" : "USA",
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  {
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      "meta" : {
        "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_fd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition fd84a8b5-9e96-451c-a5c6-097c943eb38a</b></p><a name=\"fd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </a><a name=\"hcfd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </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>: Citric acid</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><p><b>manufacturer</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></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 XF417D3PSL}\">XF417D3PSL</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>ANHYDROUS CITRIC ACID</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></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></tr></table></div>"
      },
      "identifier" : [{
        "value" : "Citric acid"
      }],
      "classification" : [{
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C48807",
          "display" : "Chemical"
        }]
      }],
      "grade" : [{
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C134009",
          "display" : "Company Standard"
        }]
      }],
      "manufacturer" : [{
        "reference" : "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
      }],
      "supplier" : [{
        "reference" : "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"
      }],
      "code" : [{
        "code" : {
          "coding" : [{
            "system" : "http://fdasis.nlm.nih.gov",
            "code" : "XF417D3PSL"
          }]
        }
      }],
      "name" : [{
        "name" : "ANHYDROUS CITRIC ACID",
        "type" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C203355",
            "display" : "GSRS Preferred Term"
          }]
        },
        "preferred" : true
      }],
      "sourceMaterial" : {
        "type" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C48807",
            "display" : "Chemical"
          }]
        }
      }
    }
  },
  {
    "fullUrl" : "urn:uuid:d3a11b25-e160-4688-b807-6383364096fd",
    "resource" : {
      "resourceType" : "SubstanceDefinition",
      "id" : "d3a11b25-e160-4688-b807-6383364096fd",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_d3a11b25-e160-4688-b807-6383364096fd\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition d3a11b25-e160-4688-b807-6383364096fd</b></p><a name=\"d3a11b25-e160-4688-b807-6383364096fd\"> </a><a name=\"hcd3a11b25-e160-4688-b807-6383364096fd\"> </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>: water</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 C176793}\">BP</span></p><p><b>manufacturer</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></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 059QF0KO0R}\">059QF0KO0R</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>WATER</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></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></tr></table></div>"
      },
      "identifier" : [{
        "value" : "water"
      }],
      "classification" : [{
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C48807",
          "display" : "Chemical"
        }]
      }],
      "grade" : [{
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C176793",
          "display" : "BP"
        }]
      }],
      "manufacturer" : [{
        "reference" : "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
      }],
      "supplier" : [{
        "reference" : "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"
      }],
      "code" : [{
        "code" : {
          "coding" : [{
            "system" : "http://fdasis.nlm.nih.gov",
            "code" : "059QF0KO0R"
          }]
        }
      }],
      "name" : [{
        "name" : "WATER",
        "type" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C203355",
            "display" : "GSRS Preferred Term"
          }]
        },
        "preferred" : true
      }],
      "sourceMaterial" : {
        "type" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C48807",
            "display" : "Chemical"
          }]
        }
      }
    }
  },
  {
    "fullUrl" : "urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e",
    "resource" : {
      "resourceType" : "PlanDefinition",
      "id" : "ab241f8c-d21e-4382-a70a-52190dbdf07e",
      "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_ab241f8c-d21e-4382-a70a-52190dbdf07e\"> </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;\">ab241f8c-d21e-4382-a70a-52190dbdf07e</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>RawCitricacid</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;\">Raw Material (Carrageenan) 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:0efb1188-04f0-44ba-bfe7-ca6169ca8703</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;\">2023-11-28</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 Identification:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            <b>Then:</b>\n                            <table class=\"grid-dict\">\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Identification A:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Identification B:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Identification C:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Identification D:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                            </table>\n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Microbial Limits:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            <b>Then:</b>\n                            <table class=\"grid-dict\">\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Total Bacterial Count:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Salmonella:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Escherichia Coli:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                            </table>\n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Elemental 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> Cadmium (Cd):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Mercury (Hg):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Arsenic (As):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Lead (Pb):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                            </table>\n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Residual Solvents:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Impurity: Insoluble Matter:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Solubility in H2O:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \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" : "RawCitricacid"
      }],
      "version" : "1.0",
      "title" : "Raw Material (Carrageenan) 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:0efb1188-04f0-44ba-bfe7-ca6169ca8703"
      },
      "date" : "2023-11-28",
      "goal" : [{
        "id" : "e512320e-0ffb-47d9-922a-5415aaa4cb30",
        "description" : {
          "text" : "Viscous upon cooling"
        },
        "addresses" : [{
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134029",
            "display" : "Release"
          }]
        },
        {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134030",
            "display" : "Stability"
          }]
        }],
        "target" : [{
          "detailString" : "Viscous upon cooling"
        }]
      },
      {
        "id" : "2c6e465b-4dec-4a09-9dc5-58c480009d27",
        "description" : {
          "text" : "Kappa, iota or lambda"
        },
        "addresses" : [{
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134029",
            "display" : "Release"
          }]
        },
        {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134030",
            "display" : "Stability"
          }]
        }],
        "target" : [{
          "detailString" : "Kappa, iota or Lambda"
        }]
      },
      {
        "id" : "c233a5f7-37e2-4b2b-9f04-cf1b25534865",
        "description" : {
          "text" : "Blue, stringy precipitate forms"
        },
        "addresses" : [{
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134029",
            "display" : "Release"
          }]
        },
        {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134030",
            "display" : "Stability"
          }]
        }],
        "target" : [{
          "detailString" : "Blue stringy precipitate forms"
        }]
      },
      {
        "id" : "c759888d-1eac-4a12-aa9b-403f395f2c18",
        "description" : {
          "text" : "FTIR matches standard"
        },
        "addresses" : [{
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134029",
            "display" : "Release"
          }]
        },
        {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134030",
            "display" : "Stability"
          }]
        }],
        "target" : [{
          "detailString" : "FTIR matches standard"
        }]
      },
      {
        "id" : "66d4035c-633a-49b1-b974-e3171911f44a",
        "description" : {
          "text" : "max 200 cfu/g"
        },
        "addresses" : [{
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134029",
            "display" : "Release"
          }]
        },
        {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134030",
            "display" : "Stability"
          }]
        }],
        "target" : [{
          "detailQuantity" : {
            "value" : 200,
            "comparator" : "<=",
            "unit" : "colony forming unit",
            "system" : "http://unitsofmeasure.org",
            "code" : "[CFU]"
          }
        }]
      },
      {
        "id" : "95bf9d43-f337-4905-9c50-788b69d00843",
        "description" : {
          "text" : "Negative"
        },
        "addresses" : [{
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134029",
            "display" : "Release"
          }]
        },
        {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134030",
            "display" : "Stability"
          }]
        }],
        "target" : [{
          "detailString" : "Negative"
        }]
      },
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