Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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 1.1.6 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

Product Batch Formula (3.2.P.3.2)

Domain Overview

The Product Batch Formula bundle profile provides a mechanism for the industry to submit Module 3 CTD 3.2.P.3.2 folder content to the FDA. The contents of this section include the amount of material in a specific type of batch, in total and broken down by the components and constituents that constitute the drug product.

Implementer Instructions

  • Each 32P32 bundle is for a single drug product.
  • All batch formulas for a drug product are contained in a single bundle.

Representation in FHIR

Note: profile computable names (in parenthesis above) map to names in the Profile Map below.

CTD 3.2.P.3.2 Profile Map

eCTD Heading 3.2.P.3.2 Batch Formula BundleEctdComposition32P32CodedOrganizationDrugProductIngredientSubstanceDefinitionHandleExcipientRawBatchFormulaMedicinalProductBatchFormulaBundle Reference:StructureDefinition-cmc-ectd-document-32p32.htmlParent:CompositionReference:StructureDefinition-ectd-composition-32p32.htmlValueSets:Code system PQCMC Comp Section TypesParent:OrganizationReference:StructureDefinition-cmc-organization.htmlValueSets:Sponsor Identifier Type TerminologyParent:IngredientReference:StructureDefinition-pqcmc-dp-ingredient.htmlValueSets:Units Of MeasureParent:SubstanceDefinitionReference:StructureDefinition-pqcmc-routine-drug-substance.htmlValueSets:Substance ClassificationQuality Benchmark TerminologyParent:SubstanceDefinitionReference:StructureDefinition-pqcmc-excipient.htmlValueSets:Substance ClassificationQuality Benchmark TerminologySource Type TerminologyParent:MedicinalProductDefinitionReference:StructureDefinition-pqcmc-batch-formula-product.htmlValueSets:Pharmaceutical Dosage Form TerminologyDrug Route Of Administration TerminologyPQCMC Name Part TerminologyParent:ManufacturedItemDefinitionReference:StructureDefinition-pqcmc-product-batch-formula.htmlValueSets:Manufactured Dose Form TerminologyProduct Part Type TerminologyBatch utilization TerminologyNon-Percentage UnitsPercentage UnitsIngredient Location TerminologyUnits Of MeasureExtensionsAdditional InformationProduct Batch Ingredient Extension

Usage Patterns

Not Applicable

Examples

This example demonstrates the batch formula for a commercial batch of a drug product. This image displays the narrative as inserted in the composition text element generated by the narrative transform. The XML can be found on the Artifacts page. The XML file with the publisher narrative is on the artifacts page and in the Bundle profile. 49d3b79e-b436-a242-93ba-b706b4364ab2

Another batch formula example is a242b79e-b706-49d3-93ba-b4364ab2baa3