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 1.0.0-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

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Data Type Profile: PqAddress

pq-specific Constraints on the Address datatype dealing with US addresses.

Usage:

• Use this DataType Constraint: Sponsor Organization, Manufacturing and/or Test Site Organization and Supplier Organization

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from Address

Name	Flags	Card.	Type	Description & Constraints
Address	C	0..*	Address	An address expressed using postal conventions (as opposed to GPS or other location definition formats) addr-state: If the country is USA, then the state and postal code exist addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
line		1..2	string	Street name, number, direction & P.O. Box etc.
city	S	1..1	string	Name of city, town etc.
state	S	0..1	string	Sub-unit of country (abbreviations ok)
postalCode	S	1..1	string	Postal code for area
country	SC	1..1	string	Country must be a 3-letter country code. The codes and full names are Target Code column in the ConceptMap: ISO to GENC Country Code Mapping cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code
Documentation for this format

Constraints

Id	Grade	Path(s)	Details	Requirements
addr-state	error	Address	If the country is USA, then the state and postal code exist : country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-zip	error	Address	If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers : country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
cmc-only-ISO-3166-1-alpha-3	error	Address.country	Country must be a 3 letter country code : $this.length() = 3

Name	Flags	Card.	Type	Description & Constraints
Address	C	0..*	Address	An address expressed using postal conventions (as opposed to GPS or other location definition formats) addr-state: If the country is USA, then the state and postal code exist addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
use	?!Σ	0..1	code	home | work | temp | old | billing - purpose of this address Binding: AddressUse (required): The use of an address (home / work / etc.). Example General: home
line	Σ	1..2	string	Street name, number, direction & P.O. Box etc. This repeating element order: The order in which lines should appear in an address label Example General: 137 Nowhere Street
city	SΣ	1..1	string	Name of city, town etc. Example General: Erewhon
state	SΣ	0..1	string	Sub-unit of country (abbreviations ok)
postalCode	SΣ	1..1	string	Postal code for area Example General: 9132
country	SΣC	1..1	string	Country must be a 3-letter country code. The codes and full names are Target Code column in the ConceptMap: ISO to GENC Country Code Mapping cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Address.use	required	AddressUse http://hl7.org/fhir/ValueSet/address-use|5.0.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
addr-state	error	Address	If the country is USA, then the state and postal code exist : country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-zip	error	Address	If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers : country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
cmc-only-ISO-3166-1-alpha-3	error	Address.country	Country must be a 3 letter country code : $this.length() = 3
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())

Name	Flags	Card.	Type	Description & Constraints
Address	C	0..*	Address	An address expressed using postal conventions (as opposed to GPS or other location definition formats) addr-state: If the country is USA, then the state and postal code exist addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	home | work | temp | old | billing - purpose of this address Binding: AddressUse (required): The use of an address (home / work / etc.). Example General: home
type	Σ	0..1	code	postal | physical | both Binding: AddressType (required): The type of an address (physical / postal). Example General: both
text	Σ	0..1	string	Text representation of the address Example General: 137 Nowhere Street, Erewhon 9132
line	Σ	1..2	string	Street name, number, direction & P.O. Box etc. This repeating element order: The order in which lines should appear in an address label Example General: 137 Nowhere Street
city	SΣ	1..1	string	Name of city, town etc. Example General: Erewhon
district	Σ	0..1	string	District name (aka county) Example General: Madison
state	SΣ	0..1	string	Sub-unit of country (abbreviations ok)
postalCode	SΣ	1..1	string	Postal code for area Example General: 9132
country	SΣC	1..1	string	Country must be a 3-letter country code. The codes and full names are Target Code column in the ConceptMap: ISO to GENC Country Code Mapping cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code
period	Σ	0..1	Period	Time period when address was/is in use Example General: {"start":"2010-03-23","end":"2010-07-01"}
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Address.use	required	AddressUse http://hl7.org/fhir/ValueSet/address-use|5.0.0 from the FHIR Standard
Address.type	required	AddressType http://hl7.org/fhir/ValueSet/address-type|5.0.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
addr-state	error	Address	If the country is USA, then the state and postal code exist : country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-zip	error	Address	If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers : country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
cmc-only-ISO-3166-1-alpha-3	error	Address.country	Country must be a 3 letter country code : $this.length() = 3
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from Address

Summary

Mandatory: 4 elements
Must-Support: 4 elements

Differential View

This structure is derived from Address

Name	Flags	Card.	Type	Description & Constraints
Address	C	0..*	Address	An address expressed using postal conventions (as opposed to GPS or other location definition formats) addr-state: If the country is USA, then the state and postal code exist addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
line		1..2	string	Street name, number, direction & P.O. Box etc.
city	S	1..1	string	Name of city, town etc.
state	S	0..1	string	Sub-unit of country (abbreviations ok)
postalCode	S	1..1	string	Postal code for area
country	SC	1..1	string	Country must be a 3-letter country code. The codes and full names are Target Code column in the ConceptMap: ISO to GENC Country Code Mapping cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code
Documentation for this format

Constraints

Id	Grade	Path(s)	Details	Requirements
addr-state	error	Address	If the country is USA, then the state and postal code exist : country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-zip	error	Address	If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers : country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
cmc-only-ISO-3166-1-alpha-3	error	Address.country	Country must be a 3 letter country code : $this.length() = 3

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Address	C	0..*	Address	An address expressed using postal conventions (as opposed to GPS or other location definition formats) addr-state: If the country is USA, then the state and postal code exist addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
use	?!Σ	0..1	code	home | work | temp | old | billing - purpose of this address Binding: AddressUse (required): The use of an address (home / work / etc.). Example General: home
line	Σ	1..2	string	Street name, number, direction & P.O. Box etc. This repeating element order: The order in which lines should appear in an address label Example General: 137 Nowhere Street
city	SΣ	1..1	string	Name of city, town etc. Example General: Erewhon
state	SΣ	0..1	string	Sub-unit of country (abbreviations ok)
postalCode	SΣ	1..1	string	Postal code for area Example General: 9132
country	SΣC	1..1	string	Country must be a 3-letter country code. The codes and full names are Target Code column in the ConceptMap: ISO to GENC Country Code Mapping cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Address.use	required	AddressUse http://hl7.org/fhir/ValueSet/address-use|5.0.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
addr-state	error	Address	If the country is USA, then the state and postal code exist : country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-zip	error	Address	If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers : country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
cmc-only-ISO-3166-1-alpha-3	error	Address.country	Country must be a 3 letter country code : $this.length() = 3
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Address	C	0..*	Address	An address expressed using postal conventions (as opposed to GPS or other location definition formats) addr-state: If the country is USA, then the state and postal code exist addr-zip: If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	home | work | temp | old | billing - purpose of this address Binding: AddressUse (required): The use of an address (home / work / etc.). Example General: home
type	Σ	0..1	code	postal | physical | both Binding: AddressType (required): The type of an address (physical / postal). Example General: both
text	Σ	0..1	string	Text representation of the address Example General: 137 Nowhere Street, Erewhon 9132
line	Σ	1..2	string	Street name, number, direction & P.O. Box etc. This repeating element order: The order in which lines should appear in an address label Example General: 137 Nowhere Street
city	SΣ	1..1	string	Name of city, town etc. Example General: Erewhon
district	Σ	0..1	string	District name (aka county) Example General: Madison
state	SΣ	0..1	string	Sub-unit of country (abbreviations ok)
postalCode	SΣ	1..1	string	Postal code for area Example General: 9132
country	SΣC	1..1	string	Country must be a 3-letter country code. The codes and full names are Target Code column in the ConceptMap: ISO to GENC Country Code Mapping cmc-only-ISO-3166-1-alpha-3: Country must be a 3 letter country code
period	Σ	0..1	Period	Time period when address was/is in use Example General: {"start":"2010-03-23","end":"2010-07-01"}
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Address.use	required	AddressUse http://hl7.org/fhir/ValueSet/address-use|5.0.0 from the FHIR Standard
Address.type	required	AddressType http://hl7.org/fhir/ValueSet/address-type|5.0.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
addr-state	error	Address	If the country is USA, then the state and postal code exist : country = 'USA' implies (state.exists() and state.length() = 2 and postalCode.exists())
addr-zip	error	Address	If the country is USA, then the postal code is 5 digits with an optional dash and 4 numbers : country = 'USA' implies postalCode.matches('^[0-9]{5}(-[0-9]{4})?$')
cmc-only-ISO-3166-1-alpha-3	error	Address.country	Country must be a 3 letter country code : $this.length() = 3
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from Address

Summary

Mandatory: 4 elements
Must-Support: 4 elements

Other representations of profile: CSV, Excel, Schematron