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
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
Show Changes
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
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
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
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
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
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
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
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.
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
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.
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.
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
3 Comments
Austin Kreisler
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.
Smita Hastak
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.
Smita Hastak
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