Validation Results for FHIR_pqcmc_fda

Generated Thu Apr 04 13:00:19 UTC 2024, FHIR version 5.0.0 for hl7.fhir.us.pq-cmc-fda#1.0.0-ballot (canonical = http://hl7.org/fhir/us/pq-cmc-fda (history)). See Errors Only

Quality Checks
Publisher Version:IG Publisher Version: v1.6.4
Publication Code:pq-cmc-fda . PackageId = hl7.fhir.us.pq-cmc-fda, Canonical = http://hl7.org/fhir/us/pq-cmc-fda
Realm Check for US:

Snomed: The IG doesn't use SNOMED CT

4 Profiles not based on US Core

Publication Request:
package-idhl7.fhir.us.pq-cmc-fda
version1.0.0-ballot
pathhttp://hl7.org/fhir/us/pq-cmc-fda/2024May
Pub-Modeworking release
statusballot
Release-LabelSTU 1-ballot
sequenceSTU1
descThe May 2024 Ballot Version is the first ballot of this implementation guide.
firsttrue
categoryPharmaceutical
titlePharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
introductionThe FDA PQ-CMC FHIR IG is for submission of structured and standardized information regarding drug product quality, chemistry, manufacturing and processes controls.  This data is intended for submission to the US FDA by biopharmaceutical companies for the purpose of drug application review.
ci-buildhttps://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda
  • Error fetching package-list from http://hl7.org/fhir/us/pq-cmc-fda: Not Found
  • Proposed path for this publication should usually be the canonical with the version or sequence appended and then some kind of label (typically '-snapshot')
Supressed Messages:197 Suppressed Issues
Dependency Checks:
PackageVersionFHIRCanonicalWeb BaseComment
.. hl7.fhir.us.pq-cmc-fda1.0.0-ballotR5http://hl7.org/fhir/us/pq-cmc-fda
... hl7.fhir.uv.extensions.r51.0.0 MR5http://hl7.org/fhir/extensionshttp://hl7.org/fhir/extensions/1.0.0
... hl7.terminology5.5.0 MR4http://terminology.hl7.orghttp://terminology.hl7.org/5.5.0FHIR Version Mismatch
.... hl7.fhir.uv.extensions.r41.0.0 MR4http://hl7.org/fhir/extensionshttp://hl7.org/fhir/extensions/1.0.0FHIR Version Mismatch
Templates: hl7.fhir.template#current -> hl7.base.template#current -> fhir.base.template#current. Tools: 0.1.0
Dependent IGs:no references
Global Profiles:(none declared)
Terminology Server(s):http://tx.fhir.org/r4 (details)
HTA Analysis:no Non-HL7 references found
R5 Dependencies:(none)
Draft Dependencies:
Modifier Extensions:(none)
Previous Version Comparison: Unable to compare with previous version: Unable to find version history at http://hl7.org/fhir/us/pq-cmc-fda (Problem #1 with package-list.json at http://hl7.org/fhir/us/pq-cmc-fda: Not Found)
IPA Comparison: n/a
IPS Comparison: n/a
Summary: errors = 0, warn = 0, info = 0, broken links = 0
FilenameErrorsWarningsHints
Build Errors000
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/scratch/repo/fsh-generated/resources/ValueSet-spl-pharmaceutical-dosage-form-terminology000
/scratch/repo/fsh-generated/resources/ValueSet-substance-classification000

n/a Show Validation Information


fsh-generated/resources/Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.json Show Validation Information (27)


fsh-generated/resources/Bundle-4a7e17c1-a611-4cc7-9a71-8005a8b427ab.json Show Validation Information (12)


fsh-generated/resources/Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.json Show Validation Information (19)


fsh-generated/resources/Bundle-7cdbb042-9275-4599-a1fe-08877846bf94.json Show Validation Information (13)


fsh-generated/resources/Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.json Show Validation Information (39)


fsh-generated/resources/Bundle-bd0f0a7a-27ea-4884-801d-bd0546e80888.json Show Validation Information (40)


fsh-generated/resources/CodeSystem-cmc-ncit-dummy.json Show Validation Information (1)


fsh-generated/resources/CodeSystem-cmc-product-name-types.json Show Validation Information (1)


fsh-generated/resources/CodeSystem-cmc-relationship-types.json Show Validation Information (1)


fsh-generated/resources/CodeSystem-pqcmc-comp-section-types.json Show Validation Information (1)


fsh-generated/resources/CodeSystem-pqcmc-test-category-codes.json Show Validation Information (1)


fsh-generated/resources/Composition-260f5aa3-23d2-4999-8e5f-70f247390ee5.json Show Validation Information (1)


fsh-generated/resources/Composition-4bd1ed57-852b-42be-a9b0-355f8a2aa7d4.json Show Validation Information (1)


fsh-generated/resources/Composition-55d92f43-e328-4011-bbcf-744e3afd954f.json Show Validation Information (1)


fsh-generated/resources/Composition-5c0d341e-6e4f-457c-811d-cfaf3eb62ecd.json Show Validation Information (1)


fsh-generated/resources/Composition-5dfbbf17-05c0-441d-af66-7a66072f4ae4.json Show Validation Information (1)


fsh-generated/resources/Composition-d332acdf-4874-407b-9950-528f14c6bea2.json Show Validation Information (1)


fsh-generated/resources/DocumentReference-0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3.json Show Validation Information (1)


fsh-generated/resources/DocumentReference-22bd989e-8056-494f-9bc1-195d13428179.json Show Validation Information (1)


fsh-generated/resources/DocumentReference-d94ad7ac-b935-432f-bc68-312b6b8dcca7.json Show Validation Information (1)


fsh-generated/resources/ImplementationGuide-hl7.fhir.us.pq-cmc-fda.json Show Validation Information (1)


fsh-generated/resources/Ingredient-3791c4ce-2b43-4d7b-b195-0e5f88f28dab.json Show Validation Information (1)


fsh-generated/resources/Ingredient-7f10a35e-228d-42db-8918-6ccada78454d.json Show Validation Information (1)


fsh-generated/resources/Ingredient-d01421cc-6488-468b-a676-d3e7281875e2.json Show Validation Information (1)


fsh-generated/resources/Ingredient-fc09842a-8f71-48f2-9f9f-ff2441b2eb6f.json Show Validation Information (1)


fsh-generated/resources/ManufacturedItemDefinition-a8316fc9-8ca8-4115-81c1-9f8f84c99149.json Show Validation Information (1)


fsh-generated/resources/MedicinalProductDefinition-5772a6f2-cde1-4903-bfcf-1639340205cc.json Show Validation Information (1)


fsh-generated/resources/MedicinalProductDefinition-77ad6922-9c59-43d1-93cb-29d063cc2e8c.json Show Validation Information (1)


fsh-generated/resources/MedicinalProductDefinition-89676a69-1fe7-422c-ab00-92abe4ef6ea9.json Show Validation Information (1)


fsh-generated/resources/Organization-49438799-e286-432c-b8d8-68ac77e7f519.json Show Validation Information (1)


fsh-generated/resources/Organization-4b565cf3-5353-48af-8cd6-5ccf4e9fd579.json Show Validation Information (1)


fsh-generated/resources/Organization-4f3e9af1-306b-4fad-bf04-7881400b266a.json Show Validation Information (1)


fsh-generated/resources/Organization-8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9.json Show Validation Information (1)


fsh-generated/resources/Organization-b69435a0-45c6-4d44-9fde-b354e17408d7.json Show Validation Information (1)


fsh-generated/resources/Organization-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049.json Show Validation Information (1)


fsh-generated/resources/Organization-e165f057-5eed-4e64-8328-4438fc88fb1b.json Show Validation Information (1)


fsh-generated/resources/Organization-e875ef93-a730-4c44-bead-53663ae7f501.json Show Validation Information (1)


fsh-generated/resources/Organization-e99bddfa-c1b5-435b-bbe8-24816b4e23e5.json Show Validation Information (1)


fsh-generated/resources/PlanDefinition-37bf5cc0-33bf-478b-b84e-ccb35143ef6e.json Show Validation Information (1)


fsh-generated/resources/PlanDefinition-5819b223-d3d2-419f-b617-b3a9a3625b89.json Show Validation Information (1)


fsh-generated/resources/PlanDefinition-a2cba634-a481-4b07-9bd4-62c7ada31e1b.json Show Validation Information (1)


fsh-generated/resources/PlanDefinition-aa514363-d43f-4052-b44e-b67aa4d6dee7.json Show Validation Information (1)


fsh-generated/resources/PlanDefinition-ab241f8c-d21e-4382-a70a-52190dbdf07e.json Show Validation Information (1)


fsh-generated/resources/PlanDefinition-cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-cmc-document-reference.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-cmc-ectd-document-32p10.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-cmc-ectd-document-32s10.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-cmc-ectd-document-32s23.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-cmc-ectd-document-sp4151.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-cmc-sponsor-organization.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-content-percent.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-ectd-composition-32p10.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-ectd-composition-32s10.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-ectd-composition-32s23.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-ectd-composition-sp4151.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-mfg-test-site-organization.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-optional-denominator.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pq-additional-info-extension.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pq-cmc-address.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pq-container-closure-extension.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pq-hierarchical-level-extension.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pq-ig-version.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pq-interpretation-code-extension.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pq-order-extension.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pq-specification-type-extension.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pqcmc-component.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pqcmc-component-substance.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pqcmc-drug-product-description.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pqcmc-drug-substance-nomenclature-structure.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pqcmc-drugproduct-container-closure.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pqcmc-excipient.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pqcmc-polymorphic-form.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pqcmc-product-part.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pqcmc-quality-specification.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pqcmc-routine-drug-product.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-pqcmc-routine-drug-substance.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-strength-extension.json Show Validation Information (1)


fsh-generated/resources/StructureDefinition-supplier-organization.json Show Validation Information (1)


fsh-generated/resources/SubstanceDefinition-0efb1188-04f0-44ba-bfe7-ca6169ca8703.json Show Validation Information (1)


fsh-generated/resources/SubstanceDefinition-21b6b724-507e-4cf4-a462-93334b98d166.json Show Validation Information (1)


fsh-generated/resources/SubstanceDefinition-278736ef-2ddf-49e4-895c-3a9f34db36cf.json Show Validation Information (1)


fsh-generated/resources/SubstanceDefinition-2d70d504-8cc6-4282-81d4-b20b0a98b78b.json Show Validation Information (1)


fsh-generated/resources/SubstanceDefinition-393a14e7-3edc-4373-bbe5-9e569d504a1c.json Show Validation Information (1)


fsh-generated/resources/SubstanceDefinition-496f83ad-2365-4b12-8672-a349d99f7d67.json Show Validation Information (1)


fsh-generated/resources/SubstanceDefinition-580c28ac-1a2c-49fa-9be3-de997da5edcf.json Show Validation Information (1)


fsh-generated/resources/SubstanceDefinition-832f22b4-6f0c-41f8-9b7d-f26f55e9973c.json Show Validation Information (1)


fsh-generated/resources/SubstanceDefinition-cd84a8b5-4e96-551c-15c6-c97c943eb38a.json Show Validation Information (1)


fsh-generated/resources/SubstanceDefinition-d3a11b25-e160-4688-b807-6383364096fd.json Show Validation Information (1)


fsh-generated/resources/SubstanceDefinition-fc878c4f-a98c-427c-816b-e03ccdf0e712.json Show Validation Information (1)


fsh-generated/resources/SubstanceDefinition-fd84a8b5-9e96-451c-a5c6-097c943eb38a.json Show Validation Information (1)


fsh-generated/resources/ValueSet-capsule-classification-category.json Show Validation Information (1)


fsh-generated/resources/ValueSet-cmc-comp-section-types-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-cmc-product-name-types-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-cmc-relationship-types-vs.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-chemical-structure-datafile-type-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-closure-type-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-coating-purpose.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-conformance-to-criteria-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-container-type-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-drug-product-component-function-category-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-excipient-function-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-interpretation-code-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-manufactured-dose-form-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-name-part-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-org-identifier-type-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-product-characteristic.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-product-part-ingredient-physical-location.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-product-part-type.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-quality-benchmark-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-release-mechanism.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-release-profile.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-source-type-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-specification-status-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-specification-type-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-strength-operator-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-strength-type-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-substance-name-type.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-test-category-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-test-method-origin-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-test-usage-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-pqcmc-units-of-measure-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-spl-drug-route-of-administration-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-spl-pharmaceutical-dosage-form-terminology.json Show Validation Information (1)


fsh-generated/resources/ValueSet-substance-classification.json Show Validation Information (1)

Suppressed Messages (Warnings, hints, broken links)

Both the resource and the codeSystem are trial use. This is OK.

Codes are temporarily defined as part of the PQ-CMC-FDA implementation guide. Some but not all codes were are in NCIt by the time of ballot. When all codes are in NCIt, they will migrate to the HL7 Terminology (THO).

Codes are temporarily defined as part of the PQ-CMC-FDA implementation guide. After evaluation of an existing HL7 v3 RPS code set with almost identical content a decision will be made on this binding.

Codes are temporarily defined as part of the PQ-CMC-FDA implementation guide. Given more testing they will move to THO.

Codes are temporarily defined as part of the PQ-CMC-FDA implementation guide. They have recently been submitted to NCIt. NCIt does not support hierarchical codes and this will require consultation with TSMG.

Codes are temporarily defined as part of the PQ-CMC-FDA implementation guide. They may be replaced by FDA eCTD Terminology in NCIt, otherwise the a code system in THO will be introduced.

Drug manufactures and testing sites are identified by FEI number and DUNS numbers. National Provider Identifier (NPI), Clinical Laboratory Improvement Amendments (CLIA) Number for laboratories, and NAIC Code are not used. See US Core Ticket FHIR-44846

Loinc codes not pertinent to Drug Substances and Drug Products. This IG does not comply with US Core. See US Core Ticket FHIR-44844

National Provider Identifier (NPI), Clinical Laboratory Improvement Amendments (CLIA) Number for laboratories, and NAIC Code are not used to identify drug sponsors. See US Core Ticket FHIR-44845

Supplier Organization conflicts with US Core Organization Profile on identifier codes. National Provider Identifier (NPI), Clinical Laboratory Improvement Amendments (CLIA) Number for laboratories, and NAIC Code are not used to identify drug suppliers. See US Core Ticket FHIR-44853

The code system is required by PlanDefinition.type. http://terminology.hl7.org/CodeSystem/plan-definition-type has maturity level 2.

This IG does not use ValueSet http://hl7.org/fhir/ValueSet/jurisdiction

UNII Codes are sourced from FDA Substance Registration System System: The URI to identify UNII codes is http://fdasis.nlm.nih.gov. UNII codes are not available for validation. The UNII codes in this IG have been manually checked.

Waiting for an official update to the extensions pack for this issue. Safe to ignore. See https://chat.fhir.org/#narrow/stream/179252-IG-creation/topic/Information.20message.20on.20work-group

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