Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - 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 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: 3.2.S.2.3 Bundle

Document Details

Profile: CMC eCTD 32S23 Document

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

Document Subject

Profile: Drug Substance Handle

identifier: salicylate

classification: Chemical

grade: USP-NF

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

### Codes

- | Code
* | R16CO5Y76E

> name

> name: ACETYLSALICYLIC ACID

> type: Generic Name

> name

> name: ASPIRIN

> type: GSRS Preferred Term

> preferred: true

Document Content

## m3.2.s.3.1 elucidation of structure and other characteristics

## Additional Resources Included in Document

Entry 2 - fullUrl = urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a

Resource SubstanceDefinition:

> Profile: Drug Substance Handle

> identifier: salicylate

> classification: Chemical

> grade: USP-NF

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

> Profile: Basic 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

Entry 4 - fullUrl = urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5

Resource Organization:

> Profile: Basic Organization

> 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:

> Profile: Basic Organization

> 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:

> Profile: Excipient Drug Substance

> 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 | Part | CountryOfOrigin
> * | Plant | palmaria | palmata | whole | United States of America

Entry 7 - fullUrl = urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a

Resource SubstanceDefinition:

> Profile: Excipient Drug Substance

> identifier: Citric acid

> classification: Chemical

> grade: Company Standard

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

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

> Profile: Excipient Drug Substance

> identifier: water

> classification: Chemical

> grade: BP

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

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

> Profile: Basic Organization

> identifier: DUNS/143265625

> name: J. Jones Research

> ### Contacts

> - | Address
> * | J. Jones Research, 123 Broad Way, New York, NY, United States