Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
Generated Narrative: Composition
Resource Composition "55d92f43-e328-4011-bbcf-744e3afd954f"
Profile: eCTD Specification Composition
identifier: ExampleSpecification2
status: FINAL
type: Quality Specification (Code System PQCMC Comp Section Types#SP4151)
date: 2023-12-15 22:36:51+0000
author: See on this page: urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a
title: Quality Specification for an API
2. urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93 (PlanDefinition/cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93)
Generated Narrative: PlanDefinition
Resource PlanDefinition "cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"
Profile: Quality Specification
Specification Type: Drug Substance (PQ-CMC-FDA Temporary Codes#C134022)
Additional Information: This API is is currently characterized through a standard battery of physicochemical characterzation tests.
identifier: ExampleSpecification2
version: 1.0
title: Quality Specification for an API
type: Workflow Definition (PlanDefinitionType#workflow-definition; PQ-CMC-FDA Temporary Codes#C134010 "Tentatively Approved")
status: ACTIVE
subject: See on this page: urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf
date: 2022-12-08
approvalDate: 2022-12-08
goal
id
b304ed45-5295-4082-9827-f20e1ff0d1d3description: Negative ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
Detail[x] Negative (PQ-CMC-FDA Temporary Codes#C48793 "EQ") goal
id
d4e38c52-30f6-4bb7-ab84-99439a7266cedescription: Negative ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
Detail[x] Negative (PQ-CMC-FDA Temporary Codes#C48793 "EQ") goal
id
2abf1f19-e1b1-42e4-b943-79f5fa1642fedescription: Negative ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
Detail[x] Negative (PQ-CMC-FDA Temporary Codes#C48793 "EQ") goal
id
c0ed4a79-8f40-4d26-8845-4cea166fb627description: NMT 10 colony-forming units ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
Detail[x] 10 colony forming units (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68742 = '[CFU]') goal
id
442983b5-bbc3-4534-9f1b-5ae5e4c531c1description: NMT 100 colony-forming units ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
Detail[x] 100 colony forming units (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68742 = '[CFU]') action
id
997a8ec6-eabf-41a3-b166-ddc3dfb35c27Test Order | Stage Sequence Order: 1
title: Microbiological Examination of Nonsterile Products
code: Visual (PQ-CMC-FDA Temporary Codes#C96102 "Compendial")
reason: Microbial Limits (Hierarchical Test Category Codes#TC13)
Documentations
Type Label DOCUMENTATION USP <61> Actions
Extension LinkId Prefix Title GoalId 997a8ec6-eabf-41a3-b166-ddc3dfb35c27 Stage 1 Staphylococcus aureus b304ed45-5295-4082-9827-f20e1ff0d1d3 997a8ec6-eabf-41a3-b166-ddc3dfb35c27 Stage 2 Pseudomonas aeruginosa d4e38c52-30f6-4bb7-ab84-99439a7266ce 997a8ec6-eabf-41a3-b166-ddc3dfb35c27 Stage 3 Bacillus subtilis 2abf1f19-e1b1-42e4-b943-79f5fa1642fe 997a8ec6-eabf-41a3-b166-ddc3dfb35c27 Stage 4 Total Aerobic Microbial Count (TAMC) c0ed4a79-8f40-4d26-8845-4cea166fb627 997a8ec6-eabf-41a3-b166-ddc3dfb35c27 Stage 5 Total Yeasts and Molds Count (TYMC) 442983b5-bbc3-4534-9f1b-5ae5e4c531c1
3. urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf (SubstanceDefinition/580c28ac-1a2c-49fa-9be3-de997da5edcf)
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "580c28ac-1a2c-49fa-9be3-de997da5edcf"
Profile: Routine Drug Substance
identifier: P-Isobutylhydratropic Acid
classification: Chemical (PQ-CMC-FDA Temporary Codes#C48807)
grade: USP-NF (PQ-CMC-FDA Temporary Codes#C134006)
manufacturer: See on this page: urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5
supplier: See on this page: urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049
Codes
Code WK2XYI10QM (Unique Ingredient Identifier (UNII)#WK2XYI10QM) Names
Name Type Preferred IBUPROFENPIRIN GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355) true
4. urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a (Organization/4f3e9af1-306b-4fad-bf04-7881400b266a)
Generated Narrative: Organization
Resource Organization "4f3e9af1-306b-4fad-bf04-7881400b266a"
Profile: Sponsor Organization
identifier: DUNS/143265222
name: Wunderwerke
Contacts
Address Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
5. urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5 (Organization/e99bddfa-c1b5-435b-bbe8-24816b4e23e5)
Generated Narrative: Organization
Resource Organization "e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
identifier: DUNS/143265222, FEI/6981397
name: Vidinaid
Contacts
Address Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA
6. urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049 (Organization/d9e7c2f7-0f59-4645-bb6d-5a8dd2425049)
Generated Narrative: Organization
Resource Organization "d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"
Profile: Supplier Organization
identifier: DUNS/173265332
name: Mega Chem Supply
Contacts
Address Mega Chem Supply, 350 W Main Street, Rochester, NY, United States
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-08
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