This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v2.0.0-ballot: STU2 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. The current version which supersedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

Product Characterisation of Impurities (3.2.P.5.5)

Domain Overview

The Product Characterisation of Impurities bundle profile provides a mechanism for the industry to submit Module 3 CTD 3.2.P.5.5 folder content to the FDA. For each impurity found within the drug substance, in addition to identifying the impurity by name, and UNII if known, the content includes pictorial representations of the impurities produced as the result of elucidating the structure or characterization of the impurity through various techniques, including, but not limited to, NMR and mass spectrometry.

Implementer Instructions

• Each 32P55 bundle is for a single drug product.
• All impurities within the drug product are contained in a single bundle.
• The composition supports creation of a 32P55 bundle for a drug product that contains no impurities.
• The preferred formats for both the Impurity Structure Graphic and Analysis Graphic are .png and .svg.
• Guidance in how to prepare SD Files for ANDAs, NDAs, and BLAs is available here: Quick Guide to Creating a Structure-Data File (SD File) for Electronic Common Technical Document (eCTD) Submission. Guidance in how to prepare SD Files for DMFs is available here: Quick Guide to Creating a Structure-Data File (SD File) for DMF Submissions
  • The SD Files should be included in the 32P55 XML bundle as documented in the IG.

Representation in FHIR

• Drug Substance
  • Drug Product Impurities (DrugProductwithImpurities) profile on MedicinalProductDefinition resource
• Impurity Substance
  • Drug Substance Impurity (ImpuritySubstance) profile on SubstanceDefinition resource
• Related Organizations
  • Basic Organization (CodedOrganization) profile on the Organization resource

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

CTD 3.2.P.5.5 Profile Map

Usage Patterns

Not presently defined. Content will be added in the future when FDA PQ/CMC FHIR IG starts supporting other scenarios, for example new dosage forms such as liquids, etc.

Examples

This example demonstrates the impurities contained within a drug product that is a coated tablet that contains one bead type that has two coatings. 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. Bundle-9e8f2d16-66b1-47ec-878d-f50ae021985b