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 2.0.0-ballot 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: FHIR Document example of 3.2.P.5.1.

Document Details

Generated Narrative: Bundle Quality Specification for an example Drug Product

Document Content

32P51

Additional Resources Included in Document

Entry 1 - fullUrl = urn:uuid:d332acdf-4874-407b-9950-528f14c6bea2

Resource Composition:

Generated Narrative: Composition d332acdf-4874-407b-9950-528f14c6bea2

identifier: ExampleSpecification

status: Final

type: Specification(s)

date: 2023-12-15 22:33:13+0000

author: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000

title: Quality Specification for an example Drug Product

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:

Generated Narrative: MedicinalProductDefinition 89676a69-1fe7-422c-ab00-92abe4ef6ea9

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:

Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a

identifier: DUNS/143265222

name: Wunderwerke

Contacts

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