Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

## : 3.2.P.5.1 Bundle - JSON Representation

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    {
      "resourceType" : "Bundle",
      "id" : "SpecificationProductBundle",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151"
        ]
      },
      "identifier" : {
        "system" : "urn:ietf:rfc:3986",
        "value" : "urn:uuid:34a0748d-b199-4a2e-a5bc-0f880886fef7"
      },
      "type" : "document",
      "timestamp" : "2023-12-15T22:33:13.089Z",
      "entry" : [
        {
          "fullUrl" : "urn:uuid:d332acdf-4874-407b-9950-528f14c6bea2",
          "resource" : {
            "resourceType" : "Composition",
            "id" : "d332acdf-4874-407b-9950-528f14c6bea2",
            "meta" : {
              "profile" : [
                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151"
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            },
            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_d332acdf-4874-407b-9950-528f14c6bea2\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition d332acdf-4874-407b-9950-528f14c6bea2</b></p><a name=\"d332acdf-4874-407b-9950-528f14c6bea2\"> </a><a name=\"hcd332acdf-4874-407b-9950-528f14c6bea2\"> </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>: ExampleSpecification</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.p.5.1}\">m3.2.p.5.1 specification(s)</span></p><p><b>date</b>: 2023-12-15 22:33:13+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>: Quality Specification for an example Drug Product</p></div>"
            },
            "identifier" : [
              {
                "value" : "ExampleSpecification"
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            ],
            "status" : "final",
            "type" : {
              "coding" : [
                {
                  "system" : "http://terminology.hl7.org/CodeSystem/ICHContextOfUse",
                  "code" : "ich_3.2.p.5.1",
                  "display" : "m3.2.p.5.1 specification(s)"
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              ]
            },
            "date" : "2023-12-15T22:33:13.089Z",
            "author" : [
              {
                "reference" : "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"
              }
            ],
            "title" : "Quality Specification for an example Drug Product",
            "section" : [
              {
                "title" : "32P51",
                "entry" : [
                  {
                    "reference" : "urn:uuid:aa514363-d43f-4052-b44e-b67aa4d6dee7"
                  }
                ]
              }
            ]
          }
        },
        {
          "fullUrl" : "urn:uuid:aa514363-d43f-4052-b44e-b67aa4d6dee7",
          "resource" : {
            "resourceType" : "PlanDefinition",
            "id" : "aa514363-d43f-4052-b44e-b67aa4d6dee7",
            "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_aa514363-d43f-4052-b44e-b67aa4d6dee7\"> </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;\">aa514363-d43f-4052-b44e-b67aa4d6dee7</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>ExampleSpecification</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;\">Quality Specification for OXAZEPAM</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>C134021</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Drug Product</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:89676a69-1fe7-422c-ab00-92abe4ef6ea9</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;\">2022-12-08</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 Spectrophotometry Identification:</b> <div><p>Alternate</p>\n</div>\n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Identity - Ferric Chloride:</b> <div><p>Alternate</p>\n</div>\n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Loss on Drying:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Readily Carbonizable Sub:</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 (Ash):</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Substances insoluble in sodium carbonate TS:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Impurities - Chloride (Cl):</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Impurities - Sulfate (SO4):</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Elemental Impurities - Limits:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Limit of Free Salicylic Acid:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Organic Volatile Impurities:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Assay Dry Basis:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b> Dissolution - 30 minute:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            <b>Then:</b>\n                            <table class=\"grid-dict\">\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b>Stage 1 :</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b>Stage 2 :</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b>Stage 3 :</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \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" : [
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                "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension",
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                  ]
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            ],
            "identifier" : [
              {
                "value" : "ExampleSpecification"
              }
            ],
            "version" : "1.0",
            "title" : "Quality Specification for OXAZEPAM",
            "type" : {
              "coding" : [
                {
                  "system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
                  "code" : "workflow-definition",
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            "subjectReference" : {
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            "date" : "2022-12-08",
            "goal" : [
              {
                "id" : "32649771-1290-4386-9cf7-7a72274f22b4",
                "description" : {
                  "text" : "Average of 10 between 2-3 pH"
                },
                "addresses" : [
                  {
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                "target" : [
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                    "modifierExtension" : [
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                        "extension" : [
                          {
                            "url" : "low",
                            "valueQuantity" : {
                              "value" : 2,
                              "comparator" : ">=",
                              "unit" : "[pH]",
                              "system" : "http://unitsofmeasure.org",
                              "code" : "[pH]"
                            }
                          },
                          {
                            "url" : "high",
                            "valueQuantity" : {
                              "value" : 3,
                              "comparator" : "<",
                              "unit" : "[pH]",
                              "system" : "http://unitsofmeasure.org",
                              "code" : "[pH]"
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                        "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range"
                      }
                    ]
                  }
                ]
              },
              {
                "id" : "59a4ca76-858e-4d58-8e5f-88e75f51ec33",
                "description" : {
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              },
              {
                "id" : "b122987d-586c-481b-951c-6202e660158d",
                "description" : {
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                },
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              {
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                "description" : {
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                "id" : "b46dce64-a009-46cd-ab95-21d1d5b4df77",
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              },
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                  }
                ]
              },
              {
                "id" : "db19e3ab-e28b-4477-8bd7-2409093ed5a3",
                "description" : {
                  "text" : "Color intenssity of feriric ammonium sulfate TS is not less that than salicylic acid (0.1%) solution"
                },
                "addresses" : [
                  {
                    "coding" : [
                      {
                        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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                "id" : "82370588-7aae-4556-9262-a7f50dbd01aa",
                "description" : {
                  "text" : "Ethanol < 0.2%"
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                      {
                        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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            "id" : "89676a69-1fe7-422c-ab00-92abe4ef6ea9",
            "meta" : {
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              ]
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            "text" : {
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              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition 89676a69-1fe7-422c-ab00-92abe4ef6ea9</b></p><a name=\"89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </a><a name=\"hc89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </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-drug-product-handle.html\">Drug Product Handle</a></p></div><p><b>identifier</b>: Example2BeadDrug</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C25158}\">CAPSULE</span></p><p><b>route</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}\">ORAL</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}\">Non-Proprietary</span></p><blockquote><p><b>part</b></p><p><b>part</b>: OXAZEPAM</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}\">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 30mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">OXAZEPAM</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: PROPRANOLOL HYDROCHLORIDE</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}\">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 60mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">PROPRANOLOL HYDROCHLORIDE</span></p></blockquote></blockquote></div>"
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                    "type" : {
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                      "text" : "PROPRANOLOL HYDROCHLORIDE"
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                🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
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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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