Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan United States of America flag

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: eCTD Document for 32S23

Document Details

Generated Narrative: Bundle Control of Materials Example

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

Codes

-Code
*R16CO5Y76E

name

name: ACETYLSALICYLIC ACID

type: Generic Name

name

name: ASPIRIN

type: GSRS Preferred Term

preferred: true

Document Content

Elucidation of Structure and other Characteristics

Elucidation of Structure and other Characteristics

Elucidation of Structure and other Characteristics

Additional Resources Included in Document

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

author: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 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

-NameTypePreferred
*CarrageenanGSRS Preferred Termtrue

SourceMaterials

-TypeGenusSpeciesCountryOfOrigin
*PlantpalmariapalmataUnited 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

supplier: Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000

Codes

-Code
*XF417D3PSL

Names

-NameTypePreferred
*ANHYDROUS CITRIC ACIDGSRS Preferred Termtrue

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

supplier: Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000

Codes

-Code
*059QF0KO0R

Names

-NameTypePreferred
*WATERGSRS Preferred Termtrue

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

subject: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000

date: 2023-11-28

goal

id

e512320e-0ffb-47d9-922a-5415aaa4cb30

description: Viscous upon cooling

addresses: Release, Stability

Targets

-Detail[x]
*Viscous upon cooling

goal

id

2c6e465b-4dec-4a09-9dc5-58c480009d27

description: Kappa, iota or lambda

addresses: Release, Stability

Targets

-Detail[x]
*Kappa, iota or Lambda

goal

id

c233a5f7-37e2-4b2b-9f04-cf1b25534865

description: Blue, stringy precipitate forms

addresses: Release, Stability

Targets

-Detail[x]
*Blue stringy precipitate forms

goal

id

c759888d-1eac-4a12-aa9b-403f395f2c18

description: FTIR matches standard

addresses: Release, Stability

Targets

-Detail[x]
*FTIR matches standard

goal

id

66d4035c-633a-49b1-b974-e3171911f44a

description: max 200 cfu/g

addresses: Release, Stability

Targets

-Detail[x]
*<=200 colony forming unit (Details: UCUM code[CFU] = '[CFU]')

goal

id

95bf9d43-f337-4905-9c50-788b69d00843

description: Negative

addresses: Release, Stability

Targets

-Detail[x]
*Negative

goal

id

4e475e2c-c235-4433-b1e4-201a17e45796

description: Negative

addresses: Release, Stability

Targets

-Detail[x]
*Negative

goal

id

af4ec6c3-4590-43f7-92e0-c8dae0e76e1f

description: As Reported

addresses: Release, Stability

Targets

-Detail[x]
*As Reported

goal

id

b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73

description: As Reported

addresses: Release, Stability

Targets

-Detail[x]
*As Reported

goal

id

464f3063-0a4b-4408-9f4a-d6c0b8170097

description: <= 3 ppm

addresses: Release, Stability

Targets

-Detail[x]
*<=3 part per million (Details: UCUM code[ppm] = '[ppm]')

goal

id

03fbc16c-d4d4-40ac-8689-448bda831dac

description: <= 10 ppm

addresses: Release, Stability

Targets

-Detail[x]
*<=10 part per million (Details: UCUM code[ppm] = '[ppm]')

goal

id

28aba010-126e-4c47-8611-367cdacdd87e

description: As Reported

addresses: Release, Stability

Targets

-Detail[x]
*As Reported

goal

id

4b3aa353-3bc7-463f-b4c2-defd041da2c7

description: <= 2.0%

addresses: Release, Stability

Targets

-Detail[x]
*<=2 percent (Details: UCUM code% = '%')

goal

id

8125f603-96e7-4f3e-8b13-c15c5870e6e6

description: <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-c9366acd673a

prefix: Single Stage

title: Identification

code: Visual

reason: Identification

Documentations

-TypeLabel
*DocumentationEX-TEST-001

Actions

-TitleGoalId
*Identification Ae512320e-0ffb-47d9-922a-5415aaa4cb30
*Identification B2c6e465b-4dec-4a09-9dc5-58c480009d27
*Identification Cc233a5f7-37e2-4b2b-9f04-cf1b25534865
*Identification Dc759888d-1eac-4a12-aa9b-403f395f2c18

action

id

f7cbb73f-4220-4987-b498-c049230091ea

prefix: Single Stage

title: Microbial Limits

code: Visual

reason: Microbial Limits

Documentations

-TypeLabel
*DocumentationEX-TEST-002

Actions

-TitleGoalId
*Total Bacterial Count66d4035c-633a-49b1-b974-e3171911f44a
*Salmonella95bf9d43-f337-4905-9c50-788b69d00843
*Escherichia Coli4e475e2c-c235-4433-b1e4-201a17e45796

action

id

f5f8221c-f9ec-4b47-8ec7-90ff44f7388c

prefix: Single Stage

title: Elemental Impurities

code: UV

reason: Impurity, Elemental Impurity

Documentations

-TypeLabel
*DocumentationEX-TEST-003

Actions

-TitleGoalId
*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

prefix: Single Stage

title: Residual Solvents

code: Visual

reason: Impurity, Residual Solvent

Documentations

-TypeLabel
*DocumentationEX-TEST-004

goalId: 28aba010-126e-4c47-8611-367cdacdd87e

action

id

25a64081-a0c2-4d72-8a48-538f81fcc35f

prefix: Single Stage

title: Impurity: Insoluble Matter

code: Visual

reason: Impurity

Documentations

-TypeLabel
*DocumentationEX-TEST-005

goalId: 4b3aa353-3bc7-463f-b4c2-defd041da2c7

action

id

055a79d2-3f6b-49ec-a129-6feac5c33812

prefix: Single Stage

title: Solubility in H2O

code: Visual

reason: Solubility

Documentations

-TypeLabel
*DocumentationEX-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

subject: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000

date: 2023-12-01

goal

id

9bc2bfdf-c9b1-440a-bafe-89f2674341d4

description: White Solid

addresses: Release, Stability

Targets

-Detail[x]
*White solid

goal

id

59e2c94a-d383-4776-9b00-3b97b0741c9a

description: IR spectrum conforms to reference standard

addresses: Release, Stability

Targets

-Detail[x]
*IR spectrum conforms to reference standard

goal

id

a2ed2d13-e96a-4d7b-b825-c69afd334cf7

description: pH 3.4-4.3

addresses: Release, Stability

Targets

-ModifierExtension
*

goal

id

e046aab8-b10f-4e13-89e6-bfa869a90b38

description: residue <= 0.21%

addresses: Release, Stability

Targets

-Detail[x]
*<=0.21 percent (Details: UCUM code% = '%')

action

id

fdf5e37f-ae97-48c1-9809-33aebff37199

prefix: Single Stage

title: Appearance

code: Visual

reason: Organoleptic, Description/Appearance

Documentations

-TypeLabel
*DocumentationEX-TEST-101

goalId: 9bc2bfdf-c9b1-440a-bafe-89f2674341d4

action

id

f6da4e9e-4954-4fd1-a78a-b297fea64a6f

prefix: Single Stage

title: Identification

code: FTIR

reason: Identification

Documentations

-TypeLabel
*DocumentationEX-TEST-102

goalId: 59e2c94a-d383-4776-9b00-3b97b0741c9a

action

id

a5beeff6-dcc1-4b42-8ea1-76dea4b0da1d

prefix: Single Stage

title: [pH]

code: Visual

reason: pH

Documentations

-TypeLabel
*DocumentationEX-TEST-103

goalId: a2ed2d13-e96a-4d7b-b825-c69afd334cf7

action

id

aad4c3ce-985d-45ab-9d00-c2c01ca3813f

prefix: Single Stage

title: Residue on Ignition

code: Visual

reason: Residue on Ignition

Documentations

-TypeLabel
*DocumentationUSP <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

subject: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000

date: 2023-12-01

goal

id

1779ee35-8725-4322-ae82-89ed499f6864

description: <=12 deg

addresses: Release

Targets

-Detail[x]
*<=12 degree (Details: UCUM codedeg = 'deg')

goal

id

2897e150-8465-48c7-9269-1cda86dc3075

description: Conforms to reference standard

addresses: Release

Targets

-Detail[x]
*Conforms to reference standard

goal

id

9c86ccba-a210-4ce5-9a23-b145d9f123c6

description: Odorless

addresses: Release

Targets

-Detail[x]
*Odorless

goal

id

de0f0d85-5617-4b07-98fc-9976b2dbf216

description: <= 395mg/L

addresses: Release

Targets

-Detail[x]
*<=395 milligram (Details: UCUM codemg = 'mg')

action

id

3668eb6f-797c-4325-8f41-160c951b4adc

prefix: Single Stage

title: Color degree

code: Colorimetry

reason: Organoleptic, Color of Solution

Documentations

-TypeLabel
*DocumentationEX-TEST-201

goalId: 1779ee35-8725-4322-ae82-89ed499f6864

action

id

42cf5de4-2c64-48fc-a4d8-9e74066c36a3

prefix: Single Stage

title: Turbidity

code: Spectrophotometer

reason: Turbidity

Documentations

-TypeLabel
*DocumentationEX-TEST-202

goalId: 2897e150-8465-48c7-9269-1cda86dc3075

action

id

c552eee7-4dca-4a01-b291-5044d5132cc9

prefix: Single Stage

title: Smell and taste

code: Smell

reason: Organoleptic, Odor

Documentations

-TypeLabel
*DocumentationEX-TEST-203

goalId: 9c86ccba-a210-4ce5-9a23-b145d9f123c6

action

id

b33b402a-0dc7-4953-a7b8-aa2efeb8434f

prefix: Single Stage

title: Total hardness

code: Titration

reason: Hardness

Documentations

-TypeLabel
*DocumentationEX-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