Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
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Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions

Example Bundle: FHIR Document example of 3.2.P.5.1.

Generated Narrative: Composition

Resource Composition "d332acdf-4874-407b-9950-528f14c6bea2"

Profile: eCTD Specification Composition

identifier: ExampleSpecification

status: FINAL

type: Quality Specification (Code System PQCMC Comp Section Types#SP4151)

date: 2023-12-15 22:33:13+0000

author: See above (urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a)

title: Quality Specification for an example Drug Product

32P51

Additional Document Content

2. urn:uuid:aa514363-d43f-4052-b44e-b67aa4d6dee7 (PlanDefinition/aa514363-d43f-4052-b44e-b67aa4d6dee7)

Generated Narrative: PlanDefinition

Resource PlanDefinition "aa514363-d43f-4052-b44e-b67aa4d6dee7"

Profile: Quality Specification

Specification Type: Drug Product (Dummy NCIT Codesystem#C134021)

identifier: ExampleSpecification

version: 1.0

title: Quality Specification for Buffered Asprin

status: ACTIVE

subject: See above (urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9)

date: 2022-12-08

UseContexts

-CodeValue[x]
*Workflow Setting (Details: http://terminology.hl7.org/CodeSystem/usage-context-type code workflow = 'Workflow Setting', stated as 'Workflow Setting')Not Approved (Dummy NCIT Codesystem#C134011)

goal

id

32649771-1290-4386-9cf7-7a72274f22b4

description: Average of 10 between 2-3 pH ()

addresses: Release (Dummy NCIT Codesystem#C134029), Stability (Dummy NCIT Codesystem#C134030)

Targets

-Detail[x]
*2-3 pH

goal

id

59a4ca76-858e-4d58-8e5f-88e75f51ec33

description: Maxima only at the same wavelengths compared to reference standard ()

addresses: Release (Dummy NCIT Codesystem#C134029), Stability (Dummy NCIT Codesystem#C134030)

Targets

-Detail[x]
*Conforms (Dummy NCIT Codesystem#C48793 "EQ")

goal

id

c40aa176-e6aa-4fe4-869d-6550ee992903

description: <= 0.5 % ()

addresses: Release (Dummy NCIT Codesystem#C134029), Stability (Dummy NCIT Codesystem#C134030)

Targets

-Detail[x]
*0.5 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal

id

b122987d-586c-481b-951c-6202e660158d

description: Color of solution is clear ()

addresses: Release (Dummy NCIT Codesystem#C134029), Stability (Dummy NCIT Codesystem#C134030)

Targets

-Detail[x]
*Conforms (Dummy NCIT Codesystem#C48793 "EQ")

goal

id

929747ad-e83a-46f0-bbbc-133ee951e819

description: <= 0.05 % ()

addresses: Release (Dummy NCIT Codesystem#C134029), Stability (Dummy NCIT Codesystem#C134030)

Targets

-Detail[x]
*0.05 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal

id

8d7c85c2-7a4b-432e-ac94-226f296e4fca

description: No Particulate Matter detected ()

addresses: Release (Dummy NCIT Codesystem#C134029), Stability (Dummy NCIT Codesystem#C134030)

Targets

-Detail[x]
*pass (Dummy NCIT Codesystem#C48793 "EQ")

goal

id

de4f962a-d486-486d-8d84-f2d1635646b4

description: <= 0.014 % ()

addresses: Release (Dummy NCIT Codesystem#C134029), Stability (Dummy NCIT Codesystem#C134030)

Targets

-Detail[x]
*0.014 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal

id

b46dce64-a009-46cd-ab95-21d1d5b4df77

description: <= 0.04 % ()

addresses: Release (Dummy NCIT Codesystem#C134029), Stability (Dummy NCIT Codesystem#C134030)

Targets

-Detail[x]
*0.04 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal

id

5566f501-37e1-49fb-8783-b20c074ec0c3

description: <= 0.001 % ()

addresses: Release (Dummy NCIT Codesystem#C134029), Stability (Dummy NCIT Codesystem#C134030)

Targets

-Detail[x]
*0.001 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal

id

db19e3ab-e28b-4477-8bd7-2409093ed5a3

description: Color intenssity of feriric ammonium sulfate TS is not less that than salicylic acid (0.1%) solution ()

addresses: Release (Dummy NCIT Codesystem#C134029), Stability (Dummy NCIT Codesystem#C134030)

Targets

-Detail[x]
*pass (Dummy NCIT Codesystem#C48793 "EQ")

goal

id

82370588-7aae-4556-9262-a7f50dbd01aa

description: Ethanol < 0.2% ()

addresses: Release (Dummy NCIT Codesystem#C134029), Stability (Dummy NCIT Codesystem#C134030)

Targets

-MeasureDetail[x]
*Ethanol ()0.2 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal

id

cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2

description: Ethyl Ether < 0.1% ()

addresses: Release (Dummy NCIT Codesystem#C134029)

Targets

-MeasureDetail[x]
*Ethyl Ether ()0.1 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal

id

28ad4d5b-d975-4f6e-9792-b3d9cc7ce279

description: 1—propanol < 0.15% ()

addresses: Release (Dummy NCIT Codesystem#C134029)

Targets

-MeasureDetail[x]
*1—propanol ()0.15 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal

id

33fa051c-6b3c-4e4d-bd4e-09d39fc253b3

description: Total < 0.5% ()

addresses: Release (Dummy NCIT Codesystem#C134029)

Targets

-MeasureDetail[x]
*Total Residual Solvents ()0.5 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal

id

9100e938-42ff-4004-8473-ed5090d66f3a

description: 99.5 - 100.5 % ()

addresses: Release (Dummy NCIT Codesystem#C134029), Stability (Dummy NCIT Codesystem#C134030)

Targets

-Detail[x]
*99.5-100.5 percent

goal

id

af260128-f105-4692-ba40-49f21f12ad46

description: n=6 ()

addresses: Release (Dummy NCIT Codesystem#C134029)

Targets

-Detail[x]
*6

goal

id

31d9dcac-bf72-420b-a415-c924155a83f4

description: Each unit is NLT Q + 5% ()

addresses: Release (Dummy NCIT Codesystem#C134029)

Targets

-Detail[x]
*85 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal

id

47c0d685-0b23-4637-9af8-a554e4fad7ec

description: n=6 ()

addresses: Release (Dummy NCIT Codesystem#C134029)

Targets

-Detail[x]
*6

goal

id

14d3dee8-e024-4367-b0a2-a2a809303ee0

description: Average of 12 units (S1 + S2) is equal to or greater than Q and no unit is less than Q – 15% ()

addresses: Release (Dummy NCIT Codesystem#C134029)

target

measure: Average of 12 units ()

detail: 80 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

target

measure: unit ()

detail: 65 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

goal

id

15309a78-92a9-4cf9-aee1-452d6d2f7a91

description: Average of 24 units (S1 + S2 + S3) is equal to or greater than Q, not more than 2 units are less than Q – 15%, no unit is less than Q – 25% ()

addresses: Release (Dummy NCIT Codesystem#C134029)

target

measure: Average of 24 units ()

detail: 80 percent (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')

target

measure: units less than Q – 15% ()

detail: 2 amb a 1 units (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C92953 = '[Amb'a'1'U]')

target

measure: units less than Q – 25% ()

detail: 0 amb a 1 units (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C92953 = '[Amb'a'1'U]')

goal

id

666ace1e-bd29-4263-9ae2-2391106326bb

description: n=12 ()

addresses: Release (Dummy NCIT Codesystem#C134029)

Targets

-Detail[x]
*12

action

id

2047a6b6-e3fc-4071-8989-526297579091

Test Order | Stage Sequence Order: 1.1

prefix: Single Stage

title: Spectrophotometry Identification

description: Alternate

code: Spectrophotometry (Dummy NCIT Codesystem#C96102 "Compendial")

reason: Identification (Hierarchical Test Category Codes#TC7)

Documentations

-TypeLabel
*DOCUMENTATIONUSP <197>

goalId: 32649771-1290-4386-9cf7-7a72274f22b4

RelatedActions

-TargetIdRelationship
*84d64dd8-b799-418a-a713-a854c4d3c2b9CONCURRENT

selectionBehavior: EXACTLYONE

action

id

84d64dd8-b799-418a-a713-a854c4d3c2b9

Test Order | Stage Sequence Order: 1.2

linkId: 2047a6b6-e3fc-4071-8989-526297579091

prefix: Single Stage

title: Identity - Ferric Chloride

description: Alternate

code: HPLC (Dummy NCIT Codesystem#C96103 "Proprietary")

reason: Identification (Hierarchical Test Category Codes#TC7)

Documentations

-TypeLabel
*DOCUMENTATIONEX-TEST-01

goalId: 59a4ca76-858e-4d58-8e5f-88e75f51ec33

RelatedActions

-TargetIdRelationship
*2047a6b6-e3fc-4071-8989-526297579091CONCURRENT

selectionBehavior: EXACTLYONE

action

id

838e66ce-f4b0-47a5-8ea0-aa7882a84303

Test Order | Stage Sequence Order: 2

prefix: Single Stage

title: Loss on Drying

code: Visual (Dummy NCIT Codesystem#C96102 "Compendial")

reason: Loss on Drying (Hierarchical Test Category Codes#TC12)

Documentations

-TypeLabel
*DOCUMENTATIONUSP <731>

goalId: c40aa176-e6aa-4fe4-869d-6550ee992903

action

id

3510686b-fb93-4980-a41c-0a3754be7f37

Test Order | Stage Sequence Order: 3

prefix: Single Stage

title: Readily Carbonizable Sub

code: Visual (Dummy NCIT Codesystem#C96102 "Compendial")

reason: Organoleptic (Hierarchical Test Category Codes#TC6), Color of solution (Hierarchical Test Category Codes#SUBC22)

Documentations

-TypeLabel
*DOCUMENTATIONUSP <271>

goalId: b122987d-586c-481b-951c-6202e660158d

action

id

b2e18cc4-f494-4ef0-be34-810d8d4b439b

Test Order | Stage Sequence Order: 4

prefix: Single Stage

title: Residue on ignition (Ash)

code: Visual (Dummy NCIT Codesystem#C96102 "Compendial")

reason: Residue on Ignition (Hierarchical Test Category Codes#TC38)

Documentations

-TypeLabel
*DOCUMENTATIONUSP <281>

goalId: 929747ad-e83a-46f0-bbbc-133ee951e819

action

id

d315a1c3-dd93-498d-8ae3-dc0d4b3bec75

Test Order | Stage Sequence Order: 5

prefix: Single Stage

title: Substances insoluble in sodium carbonate TS

code: Visual (Dummy NCIT Codesystem#C96103 "Proprietary")

reason: Foreign and Particulate Matter (Hierarchical Test Category Codes#TC11)

Documentations

-TypeLabel
*DOCUMENTATIONEX-TEST-02

goalId: 8d7c85c2-7a4b-432e-ac94-226f296e4fca

action

id

6ec15bbc-a78a-4351-9ad8-fcf97e839ab9

Test Order | Stage Sequence Order: 6

prefix: Single Stage

title: Impurities - Chloride (Cl)

code: FTIR (Dummy NCIT Codesystem#C96102 "Compendial")

reason: Impurity (Hierarchical Test Category Codes#TC53), Specified identified impurity (Hierarchical Test Category Codes#SUBC92)

Documentations

-TypeLabel
*DOCUMENTATIONUSP <221>

goalId: de4f962a-d486-486d-8d84-f2d1635646b4

action

id

fa31b425-896c-4b25-b693-ccdd14e0c8ee

Test Order | Stage Sequence Order: 7

prefix: Single Stage

title: Impurities - Sulfate (SO4)

code: FTIR (Dummy NCIT Codesystem#C96102 "Compendial")

reason: Impurity (Hierarchical Test Category Codes#TC53), Specified identified impurity (Hierarchical Test Category Codes#SUBC92)

Documentations

-TypeLabel
*DOCUMENTATIONUSP <221>

goalId: b46dce64-a009-46cd-ab95-21d1d5b4df77

action

id

cef5aa1a-8770-4f78-9bc3-da9f18b77e5c

Test Order | Stage Sequence Order: 8

prefix: Single Stage

title: Elemental Impurities - Limits

code: UV (Dummy NCIT Codesystem#C96102 "Compendial")

reason: Impurity (Hierarchical Test Category Codes#TC53), elemental impurity (Hierarchical Test Category Codes#SUBC98)

Documentations

-TypeLabel
*DOCUMENTATIONUSP <231>

goalId: 5566f501-37e1-49fb-8783-b20c074ec0c3

action

id

d5871ee2-8b06-414c-91b4-4b30f5881c8a

Test Order | Stage Sequence Order: 9

prefix: Single Stage

title: Limit of Free Salicylic Acid

code: Titration (Dummy NCIT Codesystem#C96103 "Proprietary")

reason: Impurity (Hierarchical Test Category Codes#TC53), Impurities/Degradation Products/Related Substances (Hierarchical Test Category Codes#SUBC100)

Documentations

-TypeLabel
*DOCUMENTATIONEX-TEST-03

goalId: db19e3ab-e28b-4477-8bd7-2409093ed5a3

action

id

e192fc72-c4b1-419f-8098-6f65037a3962

Test Order | Stage Sequence Order: 10

prefix: Single Stage

title: Organic Volatile Impurities

code: Visual (Dummy NCIT Codesystem#C96102 "Compendial")

reason: Impurity (Hierarchical Test Category Codes#TC53), residual solvent (Hierarchical Test Category Codes#SUBC101)

Documentations

-TypeLabel
*DOCUMENTATIONUSP <467>

goalId: 82370588-7aae-4556-9262-a7f50dbd01aa, cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2, 28ad4d5b-d975-4f6e-9792-b3d9cc7ce279, 33fa051c-6b3c-4e4d-bd4e-09d39fc253b3

action

id

b7e88ea0-3c61-49db-86ec-8d01f8b7667b

Test Order | Stage Sequence Order: 11

prefix: Single Stage

title: Assay Dry Basis

code: Visual (Dummy NCIT Codesystem#C96103 "Proprietary")

reason: Assay (Hierarchical Test Category Codes#TC1), active ingredient (Hierarchical Test Category Codes#SUBC2)

Documentations

-TypeLabel
*DOCUMENTATIONEX-TEST-04

goalId: 9100e938-42ff-4004-8473-ed5090d66f3a

action

id

6d1ba5a8-6590-496a-ad6b-ca68cfda2878

Test Order | Stage Sequence Order: 12

title: Dissolution - 30 minute

code: Visual (Dummy NCIT Codesystem#C96103 "Proprietary")

reason: Dissolution (Hierarchical Test Category Codes#TC9)

Documentations

-TypeLabel
*DOCUMENTATIONEX-TEST-05

Actions

-ExtensionLinkIdPrefixGoalId
*6d1ba5a8-6590-496a-ad6b-ca68cfda2878Stage 1af260128-f105-4692-ba40-49f21f12ad46, 31d9dcac-bf72-420b-a415-c924155a83f4
*6d1ba5a8-6590-496a-ad6b-ca68cfda2878Stage 247c0d685-0b23-4637-9af8-a554e4fad7ec, 14d3dee8-e024-4367-b0a2-a2a809303ee0
*6d1ba5a8-6590-496a-ad6b-ca68cfda2878Stage 315309a78-92a9-4cf9-aee1-452d6d2f7a91, 666ace1e-bd29-4263-9ae2-2391106326bb

3. urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9 (MedicinalProductDefinition/89676a69-1fe7-422c-ab00-92abe4ef6ea9)

Generated Narrative: MedicinalProductDefinition

Resource MedicinalProductDefinition "89676a69-1fe7-422c-ab00-92abe4ef6ea9"

Profile: Routine Drug Product

identifier: Example2BeadDrug

combinedPharmaceuticalDoseForm: CAPSULE (Dummy NCIT Codesystem#C25158)

route: ORAL (Dummy NCIT Codesystem#C38288)

name

productName: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg

type: Non-Proprietary (Product Name Types Code Types#NON)

part

part: OXAZEPAM

type: scientific name (EntityNamePartQualifierR2#SCI)

part

part: 30mg

type: strength name (EntityNamePartQualifierR2#STR)

part

part: PROPRANOLOL HYDROCHLORIDE

type: scientific name (EntityNamePartQualifierR2#SCI)

part

part: 60mg

type: strength name (EntityNamePartQualifierR2#STR)

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