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 1.1.6 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: Substance 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:
Generated Narrative: PlanDefinition ab241f8c-d21e-4382-a70a-52190dbdf07e
Specification Status: Not Applicable
identifier: RawCitricacid
version: 1.0
title: Raw Material (Carrageenan) Specification Example
type: Workflow Definition
status: Active
date: 2023-11-28
goal
id
e512320e-0ffb-47d9-922a-5415aaa4cb30description: Viscous upon cooling
addresses: Release, Stability
Targets
Detail[x] Viscous upon cooling goal
id
2c6e465b-4dec-4a09-9dc5-58c480009d27description: Kappa, iota or lambda
addresses: Release, Stability
Targets
Detail[x] Kappa, iota or Lambda goal
id
c233a5f7-37e2-4b2b-9f04-cf1b25534865description: Blue, stringy precipitate forms
addresses: Release, Stability
Targets
Detail[x] Blue stringy precipitate forms goal
id
c759888d-1eac-4a12-aa9b-403f395f2c18description: FTIR matches standard
addresses: Release, Stability
Targets
Detail[x] FTIR matches standard goal
id
66d4035c-633a-49b1-b974-e3171911f44adescription: max 200 cfu/g
addresses: Release, Stability
Targets
Detail[x] <=200 colony forming unit (Details: UCUM code[CFU] = '[CFU]') goal
id
95bf9d43-f337-4905-9c50-788b69d00843description: Negative
addresses: Release, Stability
Targets
Detail[x] Negative goal
id
4e475e2c-c235-4433-b1e4-201a17e45796description: Negative
addresses: Release, Stability
Targets
Detail[x] Negative goal
id
af4ec6c3-4590-43f7-92e0-c8dae0e76e1fdescription: As Reported
addresses: Release, Stability
Targets
Detail[x] As Reported goal
id
b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73description: As Reported
addresses: Release, Stability
Targets
Detail[x] As Reported goal
id
464f3063-0a4b-4408-9f4a-d6c0b8170097description: <= 3 ppm
addresses: Release, Stability
Targets
Detail[x] <=3 part per million (Details: UCUM code[ppm] = '[ppm]') goal
id
03fbc16c-d4d4-40ac-8689-448bda831dacdescription: <= 10 ppm
addresses: Release, Stability
Targets
Detail[x] <=10 part per million (Details: UCUM code[ppm] = '[ppm]') goal
id
28aba010-126e-4c47-8611-367cdacdd87edescription: As Reported
addresses: Release, Stability
Targets
Detail[x] As Reported goal
id
4b3aa353-3bc7-463f-b4c2-defd041da2c7description: <= 2.0%
addresses: Release, Stability
Targets
Detail[x] <=2 percent (Details: UCUM code% = '%') goal
id
8125f603-96e7-4f3e-8b13-c15c5870e6e6description: <30ml H2O @ 25C
addresses: Release, Stability
target
detail: <=30 milliliter (Details: UCUM codemL = 'mL')
target
detail: <=25 degree Celsius (Details: UCUM codeCel = 'Cel')
action
id
428fa917-a7d3-4515-9b48-c9366acd673aprefix: Single Stage
title: Identification
code: Visual
reason: Identification
Documentations
Type Label Documentation EX-TEST-001 Actions
Title GoalId Identification A e512320e-0ffb-47d9-922a-5415aaa4cb30 Identification B 2c6e465b-4dec-4a09-9dc5-58c480009d27 Identification C c233a5f7-37e2-4b2b-9f04-cf1b25534865 Identification D c759888d-1eac-4a12-aa9b-403f395f2c18 action
id
f7cbb73f-4220-4987-b498-c049230091eaprefix: Single Stage
title: Microbial Limits
code: Visual
reason: Microbial Limits
Documentations
Type Label Documentation EX-TEST-002 Actions
Title GoalId Total Bacterial Count 66d4035c-633a-49b1-b974-e3171911f44a Salmonella 95bf9d43-f337-4905-9c50-788b69d00843 Escherichia Coli 4e475e2c-c235-4433-b1e4-201a17e45796 action
id
f5f8221c-f9ec-4b47-8ec7-90ff44f7388cprefix: Single Stage
title: Elemental Impurities
code: UV
reason: Impurity, Elemental Impurity
Documentations
Type Label Documentation EX-TEST-003 Actions
Title GoalId Cadmium (Cd) af4ec6c3-4590-43f7-92e0-c8dae0e76e1f Mercury (Hg) b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73 Arsenic (As) 464f3063-0a4b-4408-9f4a-d6c0b8170097 Lead (Pb) 03fbc16c-d4d4-40ac-8689-448bda831dac action
id
37b44e91-529a-4d87-843b-ec3dd172c09fprefix: Single Stage
title: Residual Solvents
code: Visual
reason: Impurity, Residual Solvent
Documentations
Type Label Documentation EX-TEST-004 goalId: 28aba010-126e-4c47-8611-367cdacdd87e
action
id
25a64081-a0c2-4d72-8a48-538f81fcc35fprefix: Single Stage
title: Impurity: Insoluble Matter
code: Visual
reason: Impurity
Documentations
Type Label Documentation EX-TEST-005 goalId: 4b3aa353-3bc7-463f-b4c2-defd041da2c7
action
id
055a79d2-3f6b-49ec-a129-6feac5c33812prefix: Single Stage
title: Solubility in H2O
code: Visual
reason: Solubility
Documentations
Type Label Documentation EX-TEST-006 goalId: 8125f603-96e7-4f3e-8b13-c15c5870e6e6
Entry 10 - fullUrl = urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b
Resource PlanDefinition:
Generated Narrative: PlanDefinition a2cba634-a481-4b07-9bd4-62c7ada31e1b
Specification Status: Not Applicable
identifier: CitricAcidSpecification
version: 1.0
title: Citric acid specification Example
type: Workflow Definition
status: Active
date: 2023-12-01
goal
id
9bc2bfdf-c9b1-440a-bafe-89f2674341d4description: White Solid
addresses: Release, Stability
Targets
Detail[x] White solid goal
id
59e2c94a-d383-4776-9b00-3b97b0741c9adescription: IR spectrum conforms to reference standard
addresses: Release, Stability
Targets
Detail[x] IR spectrum conforms to reference standard goal
id
a2ed2d13-e96a-4d7b-b825-c69afd334cf7description: pH 3.4-4.3
addresses: Release, Stability
Targets
ModifierExtension goal
id
e046aab8-b10f-4e13-89e6-bfa869a90b38description: residue <= 0.21%
addresses: Release, Stability
Targets
Detail[x] <=0.21 percent (Details: UCUM code% = '%') action
id
fdf5e37f-ae97-48c1-9809-33aebff37199prefix: Single Stage
title: Appearance
code: Visual
reason: Organoleptic, Description/Appearance
Documentations
Type Label Documentation EX-TEST-101 goalId: 9bc2bfdf-c9b1-440a-bafe-89f2674341d4
action
id
f6da4e9e-4954-4fd1-a78a-b297fea64a6fprefix: Single Stage
title: Identification
code: FTIR
reason: Identification
Documentations
Type Label Documentation EX-TEST-102 goalId: 59e2c94a-d383-4776-9b00-3b97b0741c9a
action
id
a5beeff6-dcc1-4b42-8ea1-76dea4b0da1dprefix: Single Stage
title: [pH]
code: Visual
reason: pH
Documentations
Type Label Documentation EX-TEST-103 goalId: a2ed2d13-e96a-4d7b-b825-c69afd334cf7
action
id
aad4c3ce-985d-45ab-9d00-c2c01ca3813fprefix: Single Stage
title: Residue on Ignition
code: Visual
reason: Residue on Ignition
Documentations
Type Label Documentation USP <281> goalId: e046aab8-b10f-4e13-89e6-bfa869a90b38
Entry 11 - fullUrl = urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89
Resource PlanDefinition:
Generated Narrative: PlanDefinition 5819b223-d3d2-419f-b617-b3a9a3625b89
Specification Status: Not Applicable
identifier: WaterSpecification
version: 1.0
title: Water Specification Example
type: Workflow Definition
status: Active
date: 2023-12-01
goal
id
1779ee35-8725-4322-ae82-89ed499f6864description: <=12 deg
addresses: Release
Targets
Detail[x] <=12 degree (Details: UCUM codedeg = 'deg') goal
id
2897e150-8465-48c7-9269-1cda86dc3075description: Conforms to reference standard
addresses: Release
Targets
Detail[x] Conforms to reference standard goal
id
9c86ccba-a210-4ce5-9a23-b145d9f123c6description: Odorless
addresses: Release
Targets
Detail[x] Odorless goal
id
de0f0d85-5617-4b07-98fc-9976b2dbf216description: <= 395mg/L
addresses: Release
Targets
Detail[x] <=395 milligram (Details: UCUM codemg = 'mg') action
id
3668eb6f-797c-4325-8f41-160c951b4adcprefix: Single Stage
title: Color degree
code: Colorimetry
reason: Organoleptic, Color of Solution
Documentations
Type Label Documentation EX-TEST-201 goalId: 1779ee35-8725-4322-ae82-89ed499f6864
action
id
42cf5de4-2c64-48fc-a4d8-9e74066c36a3prefix: Single Stage
title: Turbidity
code: Spectrophotometer
reason: Turbidity
Documentations
Type Label Documentation EX-TEST-202 goalId: 2897e150-8465-48c7-9269-1cda86dc3075
action
id
c552eee7-4dca-4a01-b291-5044d5132cc9prefix: Single Stage
title: Smell and taste
code: Smell
reason: Organoleptic, Odor
Documentations
Type Label Documentation EX-TEST-203 goalId: 9c86ccba-a210-4ce5-9a23-b145d9f123c6
action
id
b33b402a-0dc7-4953-a7b8-aa2efeb8434fprefix: Single Stage
title: Total hardness
code: Titration
reason: Hardness
Documentations
Type Label Documentation EX-TEST-204 goalId: de0f0d85-5617-4b07-98fc-9976b2dbf216
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