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

## Example Bundle: 3.2.P.5.1 Bundle

Document Details

Profile: CMC eCTD SP4151 Document

Final Document at 2023-12-15 22:33:13+0000 by Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 for

Document Content

## 32P51

## Additional Resources Included in Document

Entry 2 - fullUrl = urn:uuid:aa514363-d43f-4052-b44e-b67aa4d6dee7

Resource PlanDefinition:

> Id: | aa514363-d43f-4052-b44e-b67aa4d6dee7
> Version: | 1.0
> | ExampleSpecification
> Title: | Quality Specification for OXAZEPAM
> Type: | system: http://terminology.hl7.org/CodeSystem/plan-definition-type code: workflow-definition display: Workflow Definition system: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl code: C134021 display: Drug Product
> Subject: | reference: urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9
> Date: | 2022-12-08
> Actions: |
> Single Stage Spectrophotometry Identification: Alternate
> Single Stage Identity - Ferric Chloride: Alternate
> Single Stage Loss on Drying:
> Single Stage Readily Carbonizable Sub:
> Single Stage Residue on ignition (Ash):
> Single Stage Substances insoluble in sodium carbonate TS:
> Single Stage Impurities - Chloride (Cl):
> Single Stage Impurities - Sulfate (SO4):
> Single Stage Elemental Impurities - Limits:
> Single Stage Limit of Free Salicylic Acid:
> Single Stage Organic Volatile Impurities:
> Single Stage Assay Dry Basis:
> Dissolution - 30 minute: Then:
> Stage 1 :
> Stage 2 :
> Stage 3 :

Entry 3 - fullUrl = urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9

Resource MedicinalProductDefinition:

> Profile: Drug Product Handle

> identifier: Example2BeadDrug

> combinedPharmaceuticalDoseForm: CAPSULE

> route: ORAL

> > name

> > productName: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg

> > type: Non-Proprietary

> > > part

> > > part: OXAZEPAM

> > > type: scientific name

> > > part

> > > part: 30mg

> > > type: OXAZEPAM

> > > part

> > > part: PROPRANOLOL HYDROCHLORIDE

> > > type: scientific name

> > > part

> > > part: 60mg

> > > type: PROPRANOLOL HYDROCHLORIDE

Entry 4 - fullUrl = urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a

Resource Organization:

> Profile: Basic Organization

> identifier: DUNS/143265222

> name: Wunderwerke

> ### Contacts

> - | Address
> * | Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478