eCTD Document for 32S23 - Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA v1.0.0-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

Example Bundle: eCTD Document for 32S23

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "cd84a8b5-4e96-551c-15c6-c97c943eb38a"

Profile: Routine Drug Substance

identifier: salicylate

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

Codes

Code

R16CO5Y76E (Unique Ingredient Identifier (UNII)#R16CO5Y76E)

name
name: ACETYLSALICYLIC ACID
type: Generic Name (PQ-CMC-FDA Temporary Codes#C97054)

name
name: ASPIRIN
type: GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)
preferred: true

Generated Narrative: Composition

Resource Composition "5c0d341e-6e4f-457c-811d-cfaf3eb62ecd"

Profile: eCTD Substance Control of Materials Composition

identifier: materials1

status: FINAL

type: Substance Control of Materials (Code System PQCMC Comp Section Types#32S23)

date: 2023-12-05 01:34:39+0000

author: See on this page: urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519

title: Control of Materials Example

Raw Material Specification

See on this page: urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e

Raw Material Specification

See on this page: urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b

Raw Material Specification

See on this page: urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89

Additional Document Content

2. urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a (SubstanceDefinition/cd84a8b5-4e96-551c-15c6-c97c943eb38a)

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "cd84a8b5-4e96-551c-15c6-c97c943eb38a"
Profile: Routine Drug Substance
identifier: salicylate
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
Codes
- Code
* R16CO5Y76E (Unique Ingredient Identifier (UNII)#R16CO5Y76E)
name
name: ACETYLSALICYLIC ACID
type: Generic Name (PQ-CMC-FDA Temporary Codes#C97054)
name
name: ASPIRIN
type: GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)
preferred: true

3. urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579 (Organization/4b565cf3-5353-48af-8cd6-5ccf4e9fd579)

Generated Narrative: Organization
Resource Organization "4b565cf3-5353-48af-8cd6-5ccf4e9fd579"
Profile: Manufacturing and/or Test Site Organization
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

4. urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5 (Organization/e99bddfa-c1b5-435b-bbe8-24816b4e23e5)

Generated Narrative: Organization
Resource Organization "e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
Profile: Manufacturing and/or Test Site Organization
identifier: DUNS/143265222, FEI/6981397
name: Vidinaid
Contacts
- Address
* Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA

5. 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

6. urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703 (SubstanceDefinition/0efb1188-04f0-44ba-bfe7-ca6169ca8703)

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "0efb1188-04f0-44ba-bfe7-ca6169ca8703"
Profile: Excipient Drug Substance
identifier: carrageenan
classification: Structurally Diverse Substance (PQ-CMC-FDA Temporary Codes#C3641132)
grade: Company Standard (PQ-CMC-FDA Temporary Codes#C134009)
manufacturer: See on this page: urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579
Codes
- Code
* 5C69YCD2YJ (Unique Ingredient Identifier (UNII)#5C69YCD2YJ)
Names
- Name Type Preferred
* Carrageenan GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355) true
SourceMaterials
- Type Genus Species CountryOfOrigin
* Plant (PQ-CMC-FDA Temporary Codes#C14258) palmaria () palmata () United States of America (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#USA)

7. urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a (SubstanceDefinition/fd84a8b5-9e96-451c-a5c6-097c943eb38a)

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "fd84a8b5-9e96-451c-a5c6-097c943eb38a"
Profile: Excipient Drug Substance
identifier: Citric acid
classification: Chemical (PQ-CMC-FDA Temporary Codes#C48807)
grade: Company Standard (PQ-CMC-FDA Temporary Codes#C134009)
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
* XF417D3PSL (Unique Ingredient Identifier (UNII)#XF417D3PSL)
Names
- Name Type Preferred
* ANHYDROUS CITRIC ACID GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355) true
SourceMaterials
- Type
* Chemical (PQ-CMC-FDA Temporary Codes#C48807)

8. urn:uuid:d3a11b25-e160-4688-b807-6383364096fd (SubstanceDefinition/d3a11b25-e160-4688-b807-6383364096fd)

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "d3a11b25-e160-4688-b807-6383364096fd"
Profile: Excipient Drug Substance
identifier: water
classification: Chemical (PQ-CMC-FDA Temporary Codes#C48807)
grade: BP (PQ-CMC-FDA Temporary Codes#C176793)
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
* 059QF0KO0R (Unique Ingredient Identifier (UNII)#059QF0KO0R)
Names
- Name Type Preferred
* WATER GSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355) true
SourceMaterials
- Type
* Chemical (PQ-CMC-FDA Temporary Codes#C48807)

9. urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e (PlanDefinition/ab241f8c-d21e-4382-a70a-52190dbdf07e)

Generated Narrative: PlanDefinition
Resource PlanDefinition "ab241f8c-d21e-4382-a70a-52190dbdf07e"
Profile: Quality Specification
Specification Type: Raw Materials/Excipients/Intermediates/Reagents (PQ-CMC-FDA Temporary Codes#C133931)
identifier: RawCitricacid
version: 1.0
title: Raw Material (Carrageenan) Specification Example
type: Workflow Definition (PlanDefinitionType#workflow-definition; PQ-CMC-FDA Temporary Codes#C48660 "Not Applicable")
status: ACTIVE
subject: See on this page: urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703
date: 2023-11-28
goal
id
e512320e-0ffb-47d9-922a-5415aaa4cb30
description: Viscous upon cooling ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* Viscous upon cooling (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
2c6e465b-4dec-4a09-9dc5-58c480009d27
description: Kappa, iota or lambda ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* Kappa, iota or Lambda (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
c233a5f7-37e2-4b2b-9f04-cf1b25534865
description: Blue, stringy precipitate forms ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* Blue stringy precipitate forms (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
c759888d-1eac-4a12-aa9b-403f395f2c18
description: FTIR matches standard ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* FTIR matches standard (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
66d4035c-633a-49b1-b974-e3171911f44a
description: max 200 cfu/g ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 200 colony forming units (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68742 = '[CFU]')
goal
id
95bf9d43-f337-4905-9c50-788b69d00843
description: 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
4e475e2c-c235-4433-b1e4-201a17e45796
description: 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
af4ec6c3-4590-43f7-92e0-c8dae0e76e1f
description: As Reported ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* As Reported (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73
description: As Reported ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* As Reported (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
464f3063-0a4b-4408-9f4a-d6c0b8170097
description: <= 3 ppm ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 3 parts per million (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48523 = '[ppm]')
goal
id
03fbc16c-d4d4-40ac-8689-448bda831dac
description: <= 10 ppm ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 10 parts per million (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48523 = '[ppm]')
goal
id
28aba010-126e-4c47-8611-367cdacdd87e
description: As Reported ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* As Reported (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
4b3aa353-3bc7-463f-b4c2-defd041da2c7
description: <= 2.0% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 2 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')
goal
id
8125f603-96e7-4f3e-8b13-c15c5870e6e6
description: <30ml H2O @ 25C ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
target
detail: 30 mL (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28254 = 'mL')
target
detail: 25 degree Celsius (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C42559 = 'Cel')
action
id
428fa917-a7d3-4515-9b48-c9366acd673a
Test Order | Stage Sequence Order: 1
prefix: Single Stage
title: Identification
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Identification (Hierarchical Test Category Codes#TC7)
Documentations
- Type Label
* DOCUMENTATION EX-TEST-001
Actions
- Extension 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-c049230091ea
Test Order | Stage Sequence Order: 2
prefix: Single Stage
title: Microbial Limits
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Microbial Limits (Hierarchical Test Category Codes#TC13)
Documentations
- Type Label
* DOCUMENTATION EX-TEST-002
Actions
- Extension 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-4b47-8ec7-90ff44f7388c
Test Order | Stage Sequence Order: 3
prefix: Single Stage
title: Elemental Impurities
code: UV (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Impurity (Hierarchical Test Category Codes#TC53), elemental impurity (Hierarchical Test Category Codes#SUBC98)
Documentations
- Type Label
* DOCUMENTATION EX-TEST-003
Actions
- Extension 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-ec3dd172c09f
Test Order | Stage Sequence Order: 4
prefix: Single Stage
title: Residual Solvents
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Impurity (Hierarchical Test Category Codes#TC53), residual solvent (Hierarchical Test Category Codes#SUBC101)
Documentations
- Type Label
* DOCUMENTATION EX-TEST-004
goalId: 28aba010-126e-4c47-8611-367cdacdd87e
action
id
25a64081-a0c2-4d72-8a48-538f81fcc35f
Test Order | Stage Sequence Order: 5
prefix: Single Stage
title: Impurity: Insoluble Matter
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Impurity (Hierarchical Test Category Codes#TC53)
Documentations
- Type Label
* DOCUMENTATION EX-TEST-005
goalId: 4b3aa353-3bc7-463f-b4c2-defd041da2c7
action
id
055a79d2-3f6b-49ec-a129-6feac5c33812
Test Order | Stage Sequence Order: 6
prefix: Single Stage
title: Solubility in H2O
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Solubility (Hierarchical Test Category Codes#TC24)
Documentations
- Type Label
* DOCUMENTATION EX-TEST-006
goalId: 8125f603-96e7-4f3e-8b13-c15c5870e6e6

10. urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b (PlanDefinition/a2cba634-a481-4b07-9bd4-62c7ada31e1b)

Generated Narrative: PlanDefinition
Resource PlanDefinition "a2cba634-a481-4b07-9bd4-62c7ada31e1b"
Profile: Quality Specification
Specification Type: Raw Materials/Excipients/Intermediates/Reagents (PQ-CMC-FDA Temporary Codes#C133931)
identifier: CitricAcidSpecification
version: 1.0
title: Citric acid specification Example
type: Workflow Definition (PlanDefinitionType#workflow-definition; PQ-CMC-FDA Temporary Codes#C48660 "Not Applicable")
status: ACTIVE
subject: See on this page: urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a
date: 2023-12-01
goal
id
9bc2bfdf-c9b1-440a-bafe-89f2674341d4
description: White Solid ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* White solid (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
59e2c94a-d383-4776-9b00-3b97b0741c9a
description: IR spectrum conforms to reference standard ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* IR spectrum conforms to reference standard (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
a2ed2d13-e96a-4d7b-b825-c69afd334cf7
description: pH 3.4-4.3 ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 3.4-4.3 pH
goal
id
e046aab8-b10f-4e13-89e6-bfa869a90b38
description: residue <= 0.21% ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029), Stability (PQ-CMC-FDA Temporary Codes#C134030)
Targets
- Detail[x]
* 0.21 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')
action
id
fdf5e37f-ae97-48c1-9809-33aebff37199
Test Order | Stage Sequence Order: 1
prefix: Single Stage
title: Appearance
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Organoleptic (Hierarchical Test Category Codes#TC6), Description/Appearance (Hierarchical Test Category Codes#SUBC20)
Documentations
- Type Label
* DOCUMENTATION EX-TEST-101
goalId: 9bc2bfdf-c9b1-440a-bafe-89f2674341d4
action
id
f6da4e9e-4954-4fd1-a78a-b297fea64a6f
Test Order | Stage Sequence Order: 2
prefix: Single Stage
title: Identification
code: FTIR (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Identification (Hierarchical Test Category Codes#TC7)
Documentations
- Type Label
* DOCUMENTATION EX-TEST-102
goalId: 59e2c94a-d383-4776-9b00-3b97b0741c9a
action
id
a5beeff6-dcc1-4b42-8ea1-76dea4b0da1d
Test Order | Stage Sequence Order: 3
prefix: Single Stage
title: pH
code: Visual (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: pH (Hierarchical Test Category Codes#TC23)
Documentations
- Type Label
* DOCUMENTATION EX-TEST-103
goalId: a2ed2d13-e96a-4d7b-b825-c69afd334cf7
action
id
aad4c3ce-985d-45ab-9d00-c2c01ca3813f
Test Order | Stage Sequence Order: 4
prefix: Single Stage
title: Residue on Ignition
code: Visual (PQ-CMC-FDA Temporary Codes#C96102 "Compendial")
reason: Residue on Ignition (Hierarchical Test Category Codes#TC38)
Documentations
- Type Label
* DOCUMENTATION USP <281>
goalId: e046aab8-b10f-4e13-89e6-bfa869a90b38

11. urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89 (PlanDefinition/5819b223-d3d2-419f-b617-b3a9a3625b89)

Generated Narrative: PlanDefinition
Resource PlanDefinition "5819b223-d3d2-419f-b617-b3a9a3625b89"
Profile: Quality Specification
Specification Type: Raw Materials/Excipients/Intermediates/Reagents (PQ-CMC-FDA Temporary Codes#C133931)
identifier: WaterSpecification
version: 1.0
title: Water Specification Example
type: Workflow Definition (PlanDefinitionType#workflow-definition; PQ-CMC-FDA Temporary Codes#C48660 "Not Applicable")
status: ACTIVE
subject: See on this page: urn:uuid:d3a11b25-e160-4688-b807-6383364096fd
date: 2023-12-01
goal
id
1779ee35-8725-4322-ae82-89ed499f6864
description: <=12 deg ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
- Detail[x]
* 12 degrees of rotation (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68667 = 'deg')
goal
id
2897e150-8465-48c7-9269-1cda86dc3075
description: Conforms to reference standard ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
- Detail[x]
* Conforms to reference standard (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
9c86ccba-a210-4ce5-9a23-b145d9f123c6
description: Odorless ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
- Detail[x]
* Odorless (PQ-CMC-FDA Temporary Codes#C48793 "EQ")
goal
id
de0f0d85-5617-4b07-98fc-9976b2dbf216
description: <= 395mg/L ()
addresses: Release (PQ-CMC-FDA Temporary Codes#C134029)
Targets
- Detail[x]
* 395 milligram (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')
action
id
3668eb6f-797c-4325-8f41-160c951b4adc
Test Order | Stage Sequence Order: 1
prefix: Single Stage
title: Color degree
code: Colorimetry (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Organoleptic (Hierarchical Test Category Codes#TC6), Color of solution (Hierarchical Test Category Codes#SUBC22)
Documentations
- Type Label
* DOCUMENTATION EX-TEST-201
goalId: 1779ee35-8725-4322-ae82-89ed499f6864
action
id
42cf5de4-2c64-48fc-a4d8-9e74066c36a3
Test Order | Stage Sequence Order: 2
prefix: Single Stage
title: Turbidity
code: Spectrophotometer (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Turbidity (Hierarchical Test Category Codes#TC51)
Documentations
- Type Label
* DOCUMENTATION EX-TEST-202
goalId: 2897e150-8465-48c7-9269-1cda86dc3075
action
id
c552eee7-4dca-4a01-b291-5044d5132cc9
Test Order | Stage Sequence Order: 3
prefix: Single Stage
title: Smell and taste
code: Smell (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Organoleptic (Hierarchical Test Category Codes#TC6), Odor (Hierarchical Test Category Codes#SUBC21)
Documentations
- Type Label
* DOCUMENTATION EX-TEST-203
goalId: 9c86ccba-a210-4ce5-9a23-b145d9f123c6
action
id
b33b402a-0dc7-4953-a7b8-aa2efeb8434f
Test Order | Stage Sequence Order: 4
prefix: Single Stage
title: Total hardness
code: Titration (PQ-CMC-FDA Temporary Codes#C96103 "Proprietary")
reason: Hardness (Hierarchical Test Category Codes#TC20)
Documentations
- Type Label
* DOCUMENTATION EX-TEST-204
goalId: de0f0d85-5617-4b07-98fc-9976b2dbf216

12. urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519 (Organization/49438799-e286-432c-b8d8-68ac77e7f519)

Generated Narrative: Organization
Resource Organization "49438799-e286-432c-b8d8-68ac77e7f519"
Profile: Sponsor Organization
identifier: DUNS/143265625
name: J. Jones Research
Contacts
- Address
* J. Jones Research, 123 Broad Way, New York, NY, United States