Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.2 - 1.1.2 United States of America flag

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 1.1.2 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

Example MedicinalProductDefinition: ddd3abad-347c-4d2f-95f3-dd804e250502

Generated Narrative: MedicinalProductDefinition

ResourceMedicinalProductDefinition "ddd3abad-347c-4d2f-95f3-dd804e250502"

Profile: Drug Product Impurities

identifier: TabletCoatedBeadsCoatedAll

description: A drug product composed of one type of bead with two coatings inside a coated tablet

combinedPharmaceuticalDoseForm: TABLET, MULTILAYER (PQ-CMC-FDA Temporary Codes#C42964)

Impurities

-Reference
*urn:uuid:58ae52aa-c81e-415a-8791-e67a3195290d
*urn:uuid:ffa30c0b-8031-436a-87f1-635b3bbe5989

name

productName: LEVOTHYROXINE SODIUM ANHYDROUS 125mg

type: Non-Proprietary (Product Name Types Code Types#NON)

part

part: LEVOTHYROXINE SODIUM ANHYDROUS

type: scientific name (EntityNamePartQualifierR2#SCI)

part

part: 125mg

type: LEVOTHYROXINE SODIUM ANHYDROUS (EntityNamePartQualifierR2#STR)