Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 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-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
Document Subject
Generated Narrative: SubstanceDefinition cd84a8b5-4e96-551c-15c6-c97c943eb38a
identifier: salicylate
classification: Chemical
grade: USP-NF
manufacturer: Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000
| Code |
| R16CO5Y76E |
name
name: ACETYLSALICYLIC ACID
type: Generic Name
name
name: ASPIRIN
type: GSRS Preferred Term
preferred: true
Document Content
Entry 1 - fullUrl = urn:uuid:5c0d341e-6e4f-457c-811d-cfaf3eb62ecd
Resource Composition:
Generated Narrative: Composition 5c0d341e-6e4f-457c-811d-cfaf3eb62ecd
identifier: materials1
status: Final
type: Control of Materials
date: 2023-12-05 01:34:39+0000
title: Control of Materials Example
Entry 2 - fullUrl = urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition cd84a8b5-4e96-551c-15c6-c97c943eb38a
identifier: salicylate
classification: Chemical
grade: USP-NF
manufacturer: Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000
Codes
Code R16CO5Y76E name
name: ACETYLSALICYLIC ACID
type: Generic Name
name
name: ASPIRIN
type: GSRS Preferred Term
preferred: true
Entry 3 - fullUrl = urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579
Resource Organization:
Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579
identifier: DUNS/783452221, FEI/6913973
name: Manufacturing Site (J. Jones Research)
Contacts
Address Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States
Entry 4 - fullUrl = urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5
Resource Organization:
Generated Narrative: Organization e99bddfa-c1b5-435b-bbe8-24816b4e23e5
identifier: DUNS/143265222, FEI/6981397
name: Vidinaid
Contacts
Address Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA
Entry 5 - fullUrl = urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049
Resource Organization:
Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049
identifier: DUNS/173265332
name: Mega Chem Supply
Contacts
Address Mega Chem Supply, 350 W Main Street, Rochester, NY, United States
Entry 6 - fullUrl = urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition 0efb1188-04f0-44ba-bfe7-ca6169ca8703
identifier: carrageenan
classification: Structurally Diverse Substance
grade: Company Standard
manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000
Codes
Code 5C69YCD2YJ Names
Name Type Preferred Carrageenan GSRS Preferred Term true SourceMaterials
Type Genus Species CountryOfOrigin Plant palmaria palmata United States of America
Entry 7 - fullUrl = urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition fd84a8b5-9e96-451c-a5c6-097c943eb38a
identifier: Citric acid
classification: Chemical
grade: Company Standard
manufacturer: Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000
Codes
Code XF417D3PSL Names
Name Type Preferred ANHYDROUS CITRIC ACID GSRS Preferred Term true SourceMaterials
Type Chemical
Entry 8 - fullUrl = urn:uuid:d3a11b25-e160-4688-b807-6383364096fd
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition d3a11b25-e160-4688-b807-6383364096fd
identifier: water
classification: Chemical
grade: BP
manufacturer: Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000
Codes
Code 059QF0KO0R Names
Name Type Preferred WATER GSRS Preferred Term true SourceMaterials
Type Chemical
Entry 9 - fullUrl = urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e
Resource PlanDefinition:
Id: ab241f8c-d21e-4382-a70a-52190dbdf07e Version: 1.0 RawCitricacid
Title: Raw Material (Carrageenan) Specification Example 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: C133931
display: Raw Materials/Excipients/Intermediates/Reagents
Subject: reference: urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703
Date: 2023-11-28 Actions:
Single Stage Identification:
Then:
Identification A:
Identification B:
Identification C:
Identification D:
Single Stage Microbial Limits:
Then:
Total Bacterial Count:
Salmonella:
Escherichia Coli:
Single Stage Elemental Impurities:
Then:
Cadmium (Cd):
Mercury (Hg):
Arsenic (As):
Lead (Pb):
Single Stage Residual Solvents:
Single Stage Impurity: Insoluble Matter:
Single Stage Solubility in H2O:
Entry 10 - fullUrl = urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b
Resource PlanDefinition:
Id: a2cba634-a481-4b07-9bd4-62c7ada31e1b Version: 1.0 CitricAcidSpecification
Title: Citric acid specification Example 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: C133931
display: Raw Materials/Excipients/Intermediates/Reagents
Subject: reference: urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a
Date: 2023-12-01 Actions:
Single Stage Appearance:
Single Stage Identification:
Single Stage [pH]:
Single Stage Residue on Ignition:
Entry 11 - fullUrl = urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89
Resource PlanDefinition:
Id: 5819b223-d3d2-419f-b617-b3a9a3625b89 Version: 1.0 WaterSpecification
Title: Water Specification Example 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: C133931
display: Raw Materials/Excipients/Intermediates/Reagents
Subject: reference: urn:uuid:d3a11b25-e160-4688-b807-6383364096fd
Date: 2023-12-01 Actions:
Single Stage Color degree:
Single Stage Turbidity:
Single Stage Smell and taste:
Single Stage Total hardness:
Entry 12 - fullUrl = urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519
Resource Organization:
Generated Narrative: Organization 49438799-e286-432c-b8d8-68ac77e7f519
identifier: DUNS/143265625
name: J. Jones Research
Contacts
Address J. Jones Research, 123 Broad Way, New York, NY, United States
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-12
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