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1a. Project Name

Pharmaceutical Quality (PQ)

1b. Project ID

1537

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?

No

1e. Today's Date

1f. Name of standard being reaffirmed

1g. Project Artifact Information

1h. ISO/IEC Standard to Adopt

1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?

1j. Unit of Measure

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2b. Co-Sponsor WG

Pharmacy

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2b. Co-Sponsor WG 2

Clinical Decision Support

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

At WGMs

2b. Co-Sponsor WG 3

Clinical Quality Information

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 3 Update Periods

At WGMs

2d. Project Facilitator

Jose Galvez, Scott Gordon, Bryan Spells

2e. Other Interested Parties (and roles)

European Medicines Agency (EMA), Health Canada

2f. Modeling Facilitator

NA

2g. Publishing Facilitator

NA

2h. Vocabulary Facilitator

Norman Gregory

2i. Domain Expert Representative

FDA Reviewers: Norman Schmuff, Norman Gregory, Frank Holcombe, Michael Kerrigan

2j. Business Requirements Analyst

Smita Hastak, Catherine-Hosage Norman

2k. Conformance Facilitator

Catherine Hosage-Norman

2l. Other Facilitators

Lloyd McKenzie

2m. Implementers

US FDA, 5 Pharmaceutical companies implementing a proof-of-concept.

3a. Project Scope

The scope of this effort covers the domain of Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC), e.g., Specification, Stability, Method Validation, Batch, Batch Analysis result, etc. The objective is to develop HL7 FHIR data exchange standard for the PQ/CMC domain that covers Pharmaceutical Quality in Module 3(Quality Section) of eCTD submissions to the US FDA. Currently the baseline requirements are specific to the US, but this may expand to be global.

Attachments

3b. Project Need

To support the FDA’s regulatory needs in receiving structured and standardized data in pharmaceutical quality as described in the FDA Strategic Priorities 2014-2018.

3c. Security Risk

No

3d. External Drivers

NA

3e. Objectives/Deliverables and Target Dates

Two objectives: 1. To standardize the pharamaceutical quality data that is currently received by the FDA in eCTD Module 3 from the sponsoring organizations. 2. To use these structured elements and develop a FHIR Data exchange solution.
Deliverable: FHIR Profiles and IG in support of Pharmaceutical Quality data submission.
FHIR IG with multiple profiles-- 6 months after R5 publication

3f. Common Names / Keywords / Aliases:

Pharmaceutical Quality, Drug Quality, CMC, Product Quality

3g. Lineage

NA

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL:

https://github.com/HL7/FHIR-pq-cmc

3j. Backwards Compatibility

No

3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

Using FHIR Data types

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI EVS, UCUM, FDA SRS Listing System (UNII), CAS Number, INN, IUPAC

3o. Earliest prior release and/or version to which the compatibility applies

NA

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, R5

4c. FHIR Profiles Version

TBD

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5a. White Paper Type

5a. Is the project adopting/endorsing an externally developed IG?

No

5a. Externally developed IG is to be (select one)

5a. Specify external organization

5a. Revising Current Standard Info

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

Plan to do a phased approach for balloting. The entire PQ/CMC domain will support multiple profiles.

5d. Joint Copyright

No

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.

no

6a. External Project Collaboration

NA

6b. Content Already Developed

90% of the domain content was developed by the FDA with substantial feedback from the Pharamaceutical industry.; Coordinating with BR&R and other WGs as the requirements are represented in FHIR.

6c. Content externally developed?

No

6d. List Developers of Externally Developed Content

US FDA

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Pharmaceutical Industry, Testing Facilities/ CRO, Drug Manufacturing entities

6g. Vendors

Pharmaceutical, Other

6g. Other Vendors

LIMS vendors

6h. Providers

N/A

6h. Other Providers

6i. Realm

U.S. Realm Specific

7d. US Realm Approval Date

Jun 04, 2019

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

May 21, 2019

7c. Co-Sponsor Approval Date

Apr 12, 2021

7c. Co-Sponsor 2 Approval Date

Sep 21, 2021

7c. Co-Sponsor 3 Approval Date

Sep 21, 2021

7c. Co-Sponsor 4 Approval Date

7c. Co-Sponsor 5 Approval Date

7c. Co-Sponsor 6 Approval Date

7c. Co-Sponsor 7 Approval Date

7c. Co-Sponsor 8 Approval Date

7c. Co-Sponsor 9 Approval Date

7c. Co-Sponsor 10 Approval Date

7e. CDA MG Approval Date

7f. FMG Approval Date

May 22, 2019

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

Jun 15, 2021

7j. TSC Approval Date

Jun 21, 2021


Version

8

Modifier

Smita Hastak

Modify Date

Sep 22, 2021 14:21

1a. Project Name

Pharmaceutical Quality (PQ)

1b. Project ID

1537

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2b. Co-Sponsor WG

Pharmacy

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2b. Co-Sponsor WG 2

Clinical Decision Support

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

At WGMs

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 3 Update Periods

At WGMs

2d. Project Facilitator

Jose Galvez, Scott Gordon, Bryan Spells

2e. Other Interested Parties (and roles)

European Medicines Agency (EMA), Health Canada

2f. Modeling Facilitator

NA

2g. Publishing Facilitator

NA

2h. Vocabulary Facilitator

Norman Gregory

2i. Domain Expert Representative

FDA Reviewers: Norman Schmuff, Norman Gregory, Frank Holcombe, Michael Kerrigan

2j. Business Requirements Analyst

Smita Hastak, Catherine-Hosage Norman

2k. Conformance Facilitator

Catherine Hosage-Norman

2l. Other Facilitators

Lloyd McKenzie

2m. Implementers

US FDA, 5 Pharmaceutical companies implementing a proof-of-concept.

3a. Project Scope

The scope of this effort covers the domain of Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC), e.g., Specification, Stability, Method Validation, Batch, Batch Analysis result, etc. The objective is to develop HL7 FHIR data exchange standard for the PQ/CMC domain that covers Pharmaceutical Quality in Module 3(Quality Section) of eCTD submissions to the US FDA. Currently the baseline requirements are specific to the US, but this may expand to be global.

3b. Project Need

To support the FDA’s regulatory needs in receiving structured and standardized data in pharmaceutical quality as described in the FDA Strategic Priorities 2014-2018.

3c. Security Risk

No

3d. External Drivers

NA

3e. Objectives/Deliverables and Target Dates

Two objectives: 1. To standardize the pharamaceutical quality data that is currently received by the FDA in eCTD Module 3 from the sponsoring organizations. 2. To use these structured elements and develop a FHIR Data exchange solution.
Deliverable: FHIR Profiles and IG in support of Pharmaceutical Quality data submission.
FHIR IG with multiple profiles-- 6 months after R5 publication

3f. Common Names / Keywords / Aliases:

Pharmaceutical Quality, Drug Quality, CMC, Product Quality

3g. Lineage

NA

3i. HL7-Managed Project Document Repository URL:

https://github.com/HL7/FHIR-pq-cmc

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

Using FHIR Data types

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI EVS, UCUM, FDA SRS Listing System (UNII), CAS Number, INN, IUPAC

3o. Earliest prior release and/or version to which the compatibility applies

NA

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, R5

4c. FHIR Profiles Version

TBD

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

Plan to do a phased approach for balloting. The entire PQ/CMC domain will support multiple profiles.

5d. Joint Copyright

No

6a. External Project Collaboration

NA

6b. Content Already Developed

90% of the domain content was developed by the FDA with substantial feedback from the Pharamaceutical industry.; Coordinating with BR&R and other WGs as the requirements are represented in FHIR.

6c. Content externally developed?

No

6d. List Developers of Externally Developed Content

US FDA

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Pharmaceutical Industry, Testing Facilities/ CRO, Drug Manufacturing entities

6g. Vendors

Pharmaceutical, Other

6g. Other Vendors

LIMS vendors

6h. Providers

N/A

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

May 21, 2019

7c. Co-Sponsor Approval Date

Apr 12, 2021

7c. Co-Sponsor 2 Approval Date

Sep 21, 2021

7c. Co-Sponsor 3 Approval Date

Sep 21, 2021

7d. US Realm Approval Date

Jun 04, 2019

7f. FMG Approval Date

May 22, 2019

7i. Steering Division Approval Date

Jun 15, 2021

7j. TSC Approval Date

Jun 21, 2021

Version

7

Modifier

Smita Hastak

Modify Date

Sep 22, 2021 14:19

1a. Project Name

Pharmaceutical Quality (PQ)

1b. Project ID

1537

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2b. Co-Sponsor WG

Pharmacy

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2b. Co-Sponsor WG 2

Clinical Decision Support

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 2 Update Periods

At WGMs

2c. Co-Sponsor Level of Involvement

Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.)

2c. Co-Sponsor 3 Update Periods

At WGMs

2d. Project Facilitator

Jose Galvez, Scott Gordon, Bryan Spells

2e. Other Interested Parties (and roles)

European Medicines Agency (EMA), Health Canada

2f. Modeling Facilitator

NA

2g. Publishing Facilitator

NA

2h. Vocabulary Facilitator

Norman Gregory

2i. Domain Expert Representative

FDA Reviewers: Norman Schmuff, Norman Gregory, Frank Holcombe, Michael Kerrigan

2j. Business Requirements Analyst

Smita Hastak, Catherine-Hosage Norman

2k. Conformance Facilitator

Catherine Hosage-Norman

2l. Other Facilitators

Lloyd McKenzie

2m. Implementers

US FDA, 5 Pharmaceutical companies implementing a proof-of-concept.

3a. Project Scope

The scope of this effort covers the domain of Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC), e.g., Specification, Stability, Method Validation, Batch, Batch Analysis result, etc. The objective is to develop HL7 FHIR data exchange standard for the PQ/CMC domain that covers Pharmaceutical Quality in Module 3(Quality Section) of eCTD submissions to the US FDA. Currently the baseline requirements are specific to the US, but this may expand to be global.

3b. Project Need

To support the FDA’s regulatory needs in receiving structured and standardized data in pharmaceutical quality as described in the FDA Strategic Priorities 2014-2018.

3c. Security Risk

No

3d. External Drivers

NA

3e. Objectives/Deliverables and Target Dates

Two objectives: 1. To standardize the pharamaceutical quality data that is currently received by the FDA in eCTD Module 3 from the sponsoring organizations. 2. To use these structured elements and develop a FHIR Data exchange solution.
Deliverable: FHIR Profiles and IG in support of Pharmaceutical Quality data submission.
FHIR IG with multiple profiles-- 6 months after R5 publication

3f. Common Names / Keywords / Aliases:

Pharmaceutical Quality, Drug Quality, CMC, Product Quality

3g. Lineage

NA

3i. HL7-Managed Project Document Repository URL:

https://github.com/HL7/FHIR-pq-cmc

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

Using FHIR Data types

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI EVS, UCUM, FDA SRS Listing System (UNII), CAS Number, INN, IUPAC

3o. Earliest prior release and/or version to which the compatibility applies

NA

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, R5

4c. FHIR Profiles Version

TBD

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

Plan to do a phased approach for balloting. The entire PQ/CMC domain will support multiple profiles.

5d. Joint Copyright

No

6a. External Project Collaboration

NA

6b. Content Already Developed

90% of the domain content was developed by the FDA with substantial feedback from the Pharamaceutical industry.; Coordinating with BR&R and other WGs as the requirements are represented in FHIR.

6c. Content externally developed?

No

6d. List Developers of Externally Developed Content

US FDA

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Pharmaceutical Industry, Testing Facilities/ CRO, Drug Manufacturing entities

6g. Vendors

Pharmaceutical, Other

6g. Other Vendors

LIMS vendors

6h. Providers

N/A

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

May 21, 2019

7c. Co-Sponsor Approval Date

Apr 12, 2021

7d. US Realm Approval Date

Jun 04, 2019

7f. FMG Approval Date

May 22, 2019

7i. Steering Division Approval Date

Jun 15, 2021

7j. TSC Approval Date

Jun 21, 2021

Version

6

Modifier

Anne Wizauer

Modify Date

Aug 04, 2021 16:16

1a. Project Name

Pharmaceutical Quality (PQ)

1b. Project ID

1537

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2b. Co-Sponsor WG

Pharmacy

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Jose Galvez, Scott Gordon, Bryan Spells

2e. Other Interested Parties (and roles)

European Medicines Agency (EMA), Health Canada

2f. Modeling Facilitator

NA

2g. Publishing Facilitator

NA

2h. Vocabulary Facilitator

Norman Gregory

2i. Domain Expert Representative

FDA Reviewers: Norman Schmuff, Norman Gregory, Frank Holcombe, Michael Kerrigan

2j. Business Requirements Analyst

Smita Hastak, Catherine-Hosage Norman

2k. Conformance Facilitator

Catherine Hosage-Norman

2l. Other Facilitators

Lloyd McKenzie

2m. Implementers

US FDA, 5 Pharmaceutical companies implementing a proof-of-concept.

3a. Project Scope

The scope of this effort covers the domain of Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC), e.g., Specification, Stability, Method Validation, Batch, Batch Analysis result, etc. The objective is to develop HL7 FHIR data exchange standard for the PQ/CMC domain that covers Pharmaceutical Quality in Module 3(Quality Section) of eCTD submissions to the US FDA. Currently the baseline requirements are specific to the US, but this may expand to be global.

3b. Project Need

To support the FDA’s regulatory needs in receiving structured and standardized data in pharmaceutical quality as described in the FDA Strategic Priorities 2014-2018.

3c. Security Risk

No

3d. External Drivers

NA

3e. Objectives/Deliverables and Target Dates

Two objectives: 1. To standardize the pharamaceutical quality data that is currently received by the FDA in eCTD Module 3 from the sponsoring organizations. 2. To use these structured elements and develop a FHIR Data exchange solution.
Deliverable: FHIR Profiles and IG in support of Pharmaceutical Quality data submission.
FHIR IG with multiple profiles-- 6 months after R5 publication

3f. Common Names / Keywords / Aliases:

Pharmaceutical Quality, Drug Quality, CMC, Product Quality

3g. Lineage

NA

3i. HL7-Managed Project Document Repository URL:

https://github.com/HL7/FHIR-pq-cmc

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

Using FHIR Data types

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI EVS, UCUM, FDA SRS Listing System (UNII), CAS Number, INN, IUPAC

3o. Earliest prior release and/or version to which the compatibility applies

NA

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, R5

4c. FHIR Profiles Version

TBD

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

Plan to do a phased approach for balloting. The entire PQ/CMC domain will support multiple profiles.

5d. Joint Copyright

No

6a. External Project Collaboration

NA

6b. Content Already Developed

90% of the domain content was developed by the FDA with substantial feedback from the Pharamaceutical industry.; Coordinating with BR&R and other WGs as the requirements are represented in FHIR.

6c. Content externally developed?

No

6d. List Developers of Externally Developed Content

US FDA

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Pharmaceutical Industry, Testing Facilities/ CRO, Drug Manufacturing entities

6g. Vendors

Pharmaceutical, Other

6g. Other Vendors

LIMS vendors

6h. Providers

N/A

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

May 21, 2019

7c. Co-Sponsor Approval Date

Apr 12, 2021

7d. US Realm Approval Date

Jun 04, 2019

7f. FMG Approval Date

May 22, 2019

7i. Steering Division Approval Date

Jun 15, 2021

7j. TSC Approval Date

Jun 21, 2021

Version

5

Modifier

Anne Wizauer

Modify Date

Jun 15, 2021 20:37

1a. Project Name

Pharmaceutical Quality (PQ)

1b. Project ID

1537

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2b. Co-Sponsor WG

Pharmacy

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Jose Galvez, Scott Gordon, Bryan Spells

2e. Other Interested Parties (and roles)

European Medicines Agency (EMA), Health Canada

2f. Modeling Facilitator

NA

2g. Publishing Facilitator

NA

2h. Vocabulary Facilitator

Norman Gregory

2i. Domain Expert Representative

FDA Reviewers: Norman Schmuff, Norman Gregory, Frank Holcombe, Michael Kerrigan

2j. Business Requirements Analyst

Smita Hastak, Catherine-Hosage Norman

2k. Conformance Facilitator

Catherine Hosage-Norman

2l. Other Facilitators

Lloyd McKenzie

2m. Implementers

US FDA, 5 Pharmaceutical companies implementing a proof-of-concept.

3a. Project Scope

The scope of this effort covers the domain of Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC), e.g., Specification, Stability, Method Validation, Batch, Batch Analysis result, etc. The objective is to develop HL7 FHIR data exchange standard for the PQ/CMC domain that covers Pharmaceutical Quality in Module 3(Quality Section) of eCTD submissions to the US FDA. Currently the baseline requirements are specific to the US, but this may expand to be global.

3b. Project Need

To support the FDA’s regulatory needs in receiving structured and standardized data in pharmaceutical quality as described in the FDA Strategic Priorities 2014-2018.

3c. Security Risk

No

3d. External Drivers

NA

3e. Objectives/Deliverables and Target Dates

Two objectives: 1. To standardize the pharamaceutical quality data that is currently received by the FDA in eCTD Module 3 from the sponsoring organizations. 2. To use these structured elements and develop a FHIR Data exchange solution.
Deliverable: FHIR Profiles and IG in support of Pharmaceutical Quality data submission.
FHIR IG with multiple profiles-- 6 months after R5 publication

3f. Common Names / Keywords / Aliases:

Pharmaceutical Quality, Drug Quality, CMC, Product Quality

3g. Lineage

NA

3i. HL7-Managed Project Document Repository URL:

https://github.com/HL7/FHIR-pq-cmc

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

Using FHIR Data types

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI EVS, UCUM, FDA SRS Listing System (UNII), CAS Number, INN, IUPAC

3o. Earliest prior release and/or version to which the compatibility applies

NA

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, R5

4c. FHIR Profiles Version

TBD

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

Plan to do a phased approach for balloting. The entire PQ/CMC domain will support multiple profiles.

5d. Joint Copyright

No

6a. External Project Collaboration

NA

6b. Content Already Developed

90% of the domain content was developed by the FDA with substantial feedback from the Pharamaceutical industry.; Coordinating with BR&R and other WGs as the requirements are represented in FHIR.

6c. Content externally developed?

No

6d. List Developers of Externally Developed Content

US FDA

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Pharmaceutical Industry, Testing Facilities/ CRO, Drug Manufacturing entities

6g. Vendors

Pharmaceutical, Other

6g. Other Vendors

LIMS vendors

6h. Providers

N/A

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

May 21, 2019

7c. Co-Sponsor Approval Date

Apr 12, 2021

7d. US Realm Approval Date

Jun 04, 2019

7f. FMG Approval Date

May 22, 2019

7i. Steering Division Approval Date

Jun 15, 2021

Version

4

Modifier

Smita Hastak

Modify Date

Apr 13, 2021 19:08

1a. Project Name

Pharmaceutical Quality (PQ)

1b. Project ID

1537

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2b. Co-Sponsor WG

Pharmacy

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Jose Galvez, Scott Gordon, Bryan Spells

2e. Other Interested Parties (and roles)

European Medicines Agency (EMA), Health Canada

2f. Modeling Facilitator

NA

2g. Publishing Facilitator

NA

2h. Vocabulary Facilitator

Norman Gregory

2i. Domain Expert Representative

FDA Reviewers: Norman Schmuff, Norman Gregory, Frank Holcombe, Michael Kerrigan

2j. Business Requirements Analyst

Smita Hastak, Catherine-Hosage Norman

2k. Conformance Facilitator

Catherine Hosage-Norman

2l. Other Facilitators

Lloyd McKenzie

2m. Implementers

US FDA, 5 Pharmaceutical companies implementing a proof-of-concept.

3a. Project Scope

The scope of this effort covers the domain of Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC), e.g., Specification, Stability, Method Validation, Batch, Batch Analysis result, etc. The objective is to develop HL7 FHIR data exchange standard for the PQ/CMC domain that covers Pharmaceutical Quality in Module 3(Quality Section) of eCTD submissions to the US FDA. Currently the baseline requirements are specific to the US, but this may expand to be global.

3b. Project Need

To support the FDA’s regulatory needs in receiving structured and standardized data in pharmaceutical quality as described in the FDA Strategic Priorities 2014-2018.

3c. Security Risk

No

3d. External Drivers

NA

3e. Objectives/Deliverables and Target Dates

Two objectives: 1. To standardize the pharamaceutical quality data that is currently received by the FDA in eCTD Module 3 from the sponsoring organizations. 2. To use these structured elements and develop a FHIR Data exchange solution.
Deliverable: FHIR Profiles and IG in support of Pharmaceutical Quality data submission.
FHIR IG with multiple profiles-- 6 months after R5 publication

3f. Common Names / Keywords / Aliases:

Pharmaceutical Quality, Drug Quality, CMC, Product Quality

3g. Lineage

NA

3i. HL7-Managed Project Document Repository URL:

https://github.com/HL7/FHIR-pq-cmc

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

Using FHIR Data types

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI EVS, UCUM, FDA SRS Listing System (UNII), CAS Number, INN, IUPAC

3o. Earliest prior release and/or version to which the compatibility applies

NA

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, R5

4c. FHIR Profiles Version

TBD

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

Plan to do a phased approach for balloting. The entire PQ/CMC domain will support multiple profiles.

5d. Joint Copyright

No

6a. External Project Collaboration

NA

6b. Content Already Developed

90% of the domain content was developed by the FDA with substantial feedback from the Pharamaceutical industry.; Coordinating with BR&R and other WGs as the requirements are represented in FHIR.

6c. Content externally developed?

No

6d. List Developers of Externally Developed Content

US FDA

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Pharmaceutical Industry, Testing Facilities/ CRO, Drug Manufacturing entities

6g. Vendors

Pharmaceutical, Other

6g. Other Vendors

LIMS vendors

6h. Providers

N/A

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

May 21, 2019

7c. Co-Sponsor Approval Date

Apr 12, 2021

7d. US Realm Approval Date

Jun 04, 2019

7f. FMG Approval Date

May 22, 2019

Version

3

Modifier

Smita Hastak

Modify Date

Apr 09, 2021 17:05

1a. Project Name

Pharmaceutical Quality (PQ)

1b. Project ID

1537

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Jose Galvez, Scott Gordon, Bryan Spells

2e. Other Interested Parties (and roles)

European Medicines Agency (EMA), Health Canada

2f. Modeling Facilitator

NA

2g. Publishing Facilitator

NA

2h. Vocabulary Facilitator

Norman Gregory

2i. Domain Expert Representative

FDA Reviewers: Norman Schmuff, Norman Gregory, Frank Holcombe, Michael Kerrigan

2j. Business Requirements Analyst

Smita Hastak, Catherine-Hosage Norman

2k. Conformance Facilitator

Catherine Hosage-Norman

2l. Other Facilitators

Lloyd McKenzie

2m. Implementers

US FDA, 5 Pharmaceutical companies implementing a proof-of-concept.

3a. Project Scope

The scope of this effort covers the domain of Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC), e.g., Specification, Stability, Method Validation, Batch, Batch Analysis result, etc. The objective is to develop HL7 FHIR data exchange standard for the PQ/CMC domain that covers Pharmaceutical Quality in Module 3(Quality Section) of eCTD submissions to the US FDA. Currently the baseline requirements are specific to the US, but this may expand to be global.

3b. Project Need

To support the FDA’s regulatory needs in receiving structured and standardized data in pharmaceutical quality as described in the FDA Strategic Priorities 2014-2018.

3c. Security Risk

No

3d. External Drivers

NA

3e. Objectives/Deliverables and Target Dates

Two objectives: 1. To standardize the pharamaceutical quality data that is currently received by the FDA in eCTD Module 3 from the sponsoring organizations. 2. To use these structured elements and develop a FHIR Data exchange solution.
Deliverable: FHIR Profiles and IG in support of Pharmaceutical Quality data submission.
FHIR IG with multiple profiles-- 6 months after R5 publication

3f. Common Names / Keywords / Aliases:

Pharmaceutical Quality, Drug Quality, CMC, Product Quality

3g. Lineage

NA

3i. HL7-Managed Project Document Repository URL:

https://github.com/HL7/FHIR-pq-cmc

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

Using FHIR Data types

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI EVS, UCUM, FDA SRS Listing System (UNII), CAS Number, INN, IUPAC

3o. Earliest prior release and/or version to which the compatibility applies

NA

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, R5

4c. FHIR Profiles Version

TBD

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

Plan to do a phased approach for balloting. The entire PQ/CMC domain will support multiple profiles.

5d. Joint Copyright

No

6a. External Project Collaboration

NA

6b. Content Already Developed

90% of the domain content was developed by the FDA with substantial feedback from the Pharamaceutical industry.; Coordinating with BR&R and other WGs as the requirements are represented in FHIR.

6c. Content externally developed?

No

6d. List Developers of Externally Developed Content

US FDA

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Pharmaceutical Industry, Testing Facilities/ CRO, Drug Manufacturing entities

6g. Vendors

Pharmaceutical, Other

6g. Other Vendors

LIMS vendors

6h. Providers

N/A

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

May 21, 2019

7d. US Realm Approval Date

Jun 04, 2019

7f. FMG Approval Date

May 22, 2019

Version

2

Modifier

Smita Hastak

Modify Date

Apr 09, 2021 16:52

1a. Project Name

Pharmaceutical Quality (PQ)

1b. Project ID

1537

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Jose Galvez, Scott Gordon, Bryan Spells

2e. Other Interested Parties (and roles)

European Medicines Agency (EMA), Health Canada

2f. Modeling Facilitator

NA

2g. Publishing Facilitator

NA

2h. Vocabulary Facilitator

Norman Gregory

2i. Domain Expert Representative

FDA Reviewers: Norman Schmuff, Norman Gregory, Frank Holcombe, Michael Kerrigan

2j. Business Requirements Analyst

Smita Hastak, Catherine-Hosage Norman

2k. Conformance Facilitator

Catherine Hosage-Norman

2l. Other Facilitators

Lloyd McKenzie

2m. Implementers

US FDA, 5 Pharmaceutical companies implementing a proof-of-concept.

3a. Project Scope

The scope of this effort covers the domain of Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC), e.g., Specification, Stability, Method Validation, Batch, Batch Analysis result, etc. The objective is to develop HL7 FHIR data exchange standard for the PQ/CMC domain that covers Pharmaceutical Quality in Module 3(Quality Section) of eCTD submissions to the US FDA. Currently the baseline requirements are specific to the US, but this may expand to be global.

3b. Project Need

To support the FDA’s regulatory needs in receiving structured and standardized data in pharmaceutical quality as described in the FDA Strategic Priorities 2014-2018.

3c. Security Risk

No

3d. External Drivers

NA

3e. Objectives/Deliverables and Target Dates

Two objectives: 1. To standardize the pharamaceutical quality data that is currently received by the FDA in eCTD Module 3 from the sponsoring organizations. 2. To use these structured elements and develop a FHIR Data exchange solution.
Deliverable: FHIR Profiles and IG in support of Pharmaceutical Quality data submission.
FHIR IG with multiple profiles-- 6 months after R5 publication

3f. Common Names / Keywords / Aliases:

Pharmaceutical Quality, Drug Quality, CMC, Product Quality

3g. Lineage

NA

3i. HL7-Managed Project Document Repository URL:

https://github.com/HL7/FHIR-pq-cmc

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

Using FHIR Data types

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI EVS, UCUM, FDA SRS Listing System (UNII), CAS Number, INN, IUPAC

3o. Earliest prior release and/or version to which the compatibility applies

NA

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, R5

4c. FHIR Profiles Version

TBD

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

Plan to do a phased approach for balloting. The entire PQ/CMC domain will support multiple profiles.

5d. Joint Copyright

No

6a. External Project Collaboration

NA

6b. Content Already Developed

90% of the domain content was developed by FDA with substantial feedback from the Pharamaceutical industry.; 30% FHIR resources mapping identified. Work-in-progress to identify gaps in existing resources. Coordinating with BR&R and other WGs.

6c. Content externally developed?

No

6d. List Developers of Externally Developed Content

US FDA

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Pharmaceutical Industry, Testing Facilities/ CRO, Drug Manufacturing entities

6g. Vendors

Pharmaceutical, Other

6g. Other Vendors

LIMS vendors

6h. Providers

N/A

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

May 21, 2019

7d. US Realm Approval Date

Jun 04, 2019

7f. FMG Approval Date

May 22, 2019

Version

1

Modifier

Smita Hastak

Modify Date

Apr 06, 2021 13:48

1a. Project Name

Pharmaceutical Quality (PQ)

1b. Project ID

1537

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Jose Galvez, Scott Gordon, Bryan Spells

2e. Other Interested Parties (and roles)

European Medicines Agency (EMA), Health Canada

2f. Modeling Facilitator

NA

2g. Publishing Facilitator

NA

2h. Vocabulary Facilitator

Norman Gregory

2i. Domain Expert Representative

FDA Reviewers: Norman Schmuff, Norman Gregory, Frank Holcombe, Michael Kerrigan

2j. Business Requirements Analyst

Smita Hastak, Catherine-Hosage Norman

2k. Conformance Facilitator

Catherine Hosage-Norman

2l. Other Facilitators

Lloyd McKenzie

2m. Implementers

US FDA, 5 Pharmaceutical companies implementing a proof-of-concept.

3a. Project Scope

The scope of this effort covers the domain of Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC), e.g., Specification, Stability, Method Validation, Batch, Batch Analysis result, etc. The objective is to develop HL7 FHIR data exchange standard for the PQ/CMC domain that covers Pharmaceutical Quality in Module 3(Quality Section) of eCTD submissions to the US FDA. Currently the baseline requirements are specific to the US, but this may expand to be global.

3b. Project Need

To support the FDA’s regulatory needs in receiving structured and standardized data in pharmaceutical quality as described in the FDA Strategic Priorities 2014-2018.

3c. Security Risk

No

3d. External Drivers

NA

3e. Objectives/Deliverables and Target Dates

Two objectives: 1. To standardize the pharamaceutical quality data that is currently received by the FDA in eCTD Module 3 from the sponsoring organizations. 2. To use these structured elements and develop a FHIR Data exchange solution.
Deliverable: FHIR Profiles and IG in support of Pharmaceutical Quality data submission.
FHIR IG with multiple profiles-- 6 months after R5 publication

3f. Common Names / Keywords / Aliases:

Pharmaceutical Quality, Drug Quality, CMC, Product Quality

3g. Lineage

NA

3h. Project Dependencies

Some FHIR Resources that are needed for PQ/CMC are owned by other HL7 WGs, such as PlanDefinition, Observation, etc. Will work closely with those WGs.

3i. HL7-Managed Project Document Repository URL:

https://github.com/HL7/FHIR-pq-cmc

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3l. Reason for not using current V3 data types?

Using FHIR Data types

3m. External Vocabularies

Yes

3n. List of Vocabularies

NCI EVS, UCUM, FDA SRS Listing System (UNII), CAS Number, INN, IUPAC

3o. Earliest prior release and/or version to which the compatibility applies

NA

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR R4B, R5

4c. FHIR Profiles Version

TBD

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

Plan to do a phased approach for balloting. The entire PQ/CMC domain will most likely support multiple profiles.

5d. Joint Copyright

No

6a. External Project Collaboration

NA

6b. Content Already Developed

90% of the domain content was developed by FDA with substantial feedback from the Pharamaceutical industry.; 30% FHIR resources mapping identified. Work-in-progress to identify gaps in existing resources. Coordinating with BR&R and other WGs.

6c. Content externally developed?

No

6d. List Developers of Externally Developed Content

US FDA

6e. Is this a hosted (externally funded) project?

No

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Pharmaceutical Industry, Testing Facilities/ CRO, Drug Manufacturing entities

6g. Vendors

Pharmaceutical, Other

6g. Other Vendors

LIMS vendors

6h. Providers

N/A

6i. Realm

U.S. Realm Specific

7a. Management Group(s) to Review PSS

FHIR

7b. Sponsoring WG Approval Date

May 21, 2019

7d. US Realm Approval Date

Jun 04, 2019

7f. FMG Approval Date

May 22, 2019

3 Comments

  1. With so much externally developed content this will require ARB review before it can be approved by the TSC. The name of the project should be more informative than a couple of acronym's. The Pharmacy work group should be approached as a co-sponsor of this project.

    1. These are great suggestions!  We have re-named the project to be Pharmaceutical Quality and are requesting Pharmacy if they would be interested in becoming a co-sponsor.  Although majority of the content was initially developed at the FDA, the team has been actively working with BR&R WG members over the last 9 months to represent all the requirements in FHIR resources.

  2. CDS and CQI Work Groups voted to become co-sponsors of the PQ/CMC Project. This was voted on during the Sept. 2021 WGM during the CDS, CQI, Pharmacy and BR&R joint session at Q1 9/21/2021 – reference mtg. minutes – 2021 09 WGM Agenda