Project Summary for Data exchange industry – Pharmaceutical Quality (dX-PQ) PSS (Jira PSS-2145)
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Project Details
Number | 1800 View Ballot Items List (with NIBs) |
---|---|
Name | Data exchange industry – Pharmaceutical Quality (dX-PQ) PSS (Jira PSS-2145) |
Sponsor(s) | Biomedical Research and Regulation Work Group |
Co-Sponsor(s) | |
Steering Division | N/A |
Description | The objective of this project is to develop a universal realm Implementation Guide and profiles that will allow for the creation and exchange of CMC data internationally within biopharmaceutical companies; and between the company and its stakeholders. This project will build from and align with BR&R’s PQ project where possible.
This guide is primarily meant for developers of structured content authoring solutions; medicinal product manufacturers who produce CMC data; and those involved in pharmacovigilance analysis. Transitioning to FHIR format allows the biopharmaceutical industry to structure medicinal product information and make it more available for use in more advanced systems and services. |
Project Facilitator | Craig C. Anderson |
Status | Active Project (Resources assigned to pjt) |
SD Approval Date | Awaiting Approval |
TSC Approval Date | Jan 27, 2023 |
Type | Ballot - STU |
Objectives / Deliverables | FHIR IG R1 - STU Ballot: Target: 2024 May Ballot Cycle |
Next Milestone Date | 2024 May WGM |
Project End Date | 2024 September WGM |
Project Intent | Implementation Guide |
Project Need | Biopharmaceutical industry internal/external Chemistry, Manufacturing and Controls (CMC) data exchange - CMC accounts for over 70% of all internal and external interactions, internationally, within the company; and between the company and its stakeholders. - Despite much of the content being sourced from internal systems that support structured data (e.g., pharmaceutical development systems, manufacturing site systems), and much of it being available for reuse across many medicinal products, all CMC content is authored and managed by industry in unstructured Word or PDF. This is not sustainable given the increasing volume and frequency of work. Not only are these processes unsustainable, but they are highly manual and error-prone having the potential to impact global drug supply. - CMC content can be reused throughout the medicinal product lifecycle. For example, accurate identification when tracking product complaints; tracing AEs back to the site of manufacture; reusing the medicinal products composition in labelling. - Other key areas of the medicinal product lifecycle are transitioning to FHIR and are already in the HL7 working group portfolio. E.g., Adverse Event reporting; Real World Data (RWD); electronic Product Information (ePI); and Pharmaceutical Quality (PQ). Therefore, there is great value in ensuring industry’s CMC data exchange is also transitioned to FHIR. - FDA’s Pharmaceutical Quality project initiated this structuring of CMC data and representing it in FHIR. The current BR&R Pharmaceutical Quality project is supporting the CMC domain but specific to CMC data exchange between the biopharmaceutical industry and the FDA. - This project fits into the overall strategic goal to achieve a total transition to structured electronic data. This transition will facilitate innovation and accelerate the global exchange of CMC data and will look to leverage the parts of CMC that are already represented in FHIR by FDA’s PQ-CMC Project. |
Implementers | Implementers: Biopharmaceutical industry; structured content vendors and other software developers. |
Security Risks | |
External Drivers | |
Common Names / Keywords/ Aliases | Project Common Name/Alias: Data exchange industry - Pharmaceutical Quality (dX-PQ) |
Lineage | |
Dependancies | |
Project Document Repository | PSS: https://jira.hl7.org/browse/PSS-2145?src=confmacro |
Backwards Compatibility | N/A |
External Vocabularies | N/A |
Products | FHIR Implementation Guide |
Joint Copyright? | No |
External Pjt Collaborators | External Project Collaboration: Accumulus Synergy; PhRMA; EFPIA; ICH. |
Realm | |
HL7 Affiliate | |
Stakeholders | Regulatory Agency, Standards Development Organizations (SDOs), Other (specify in Misc. Notes below) |
Vendors | |
Providers | |
Ballot Cycle Info | |
Misc Notes | Developers of External Content: Biopharmaceutical industry; Accumulus Synergy; health authorities; ISO Working Group 6. Stakeholders: Association/Government Agency, Consultant, Healthcare IT Vendors, Pharmaceutical/Biotech, Regulatory Agency, Standards Development Organizations (SDOs), Vendor/Manufacturer |
U.S. Govt Interest? | Don't Know |
USRSC Approval | Not Needed |
FMG Approval | Not Needed |
ARB Approval | Not Needed |
Start Date | Dec 1, 2022 |
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