This project will develop a universal realm implementation guide (IG) and profiles for the exchange of Chemistry, Manufacturing and Controls (CMC) data internationally within biopharmaceutical companies, and between a company and its stakeholders.
The IG is primarily meant for developers of structured content authoring solutions, medicinal product manufacturers who produce CMC data, and those involved in pharmacovigilance analysis.
- Biopharmaceutical industry internal/external CMC data exchange accounts for over 70% of all internal and external data exchanges, internationally, within a company and between a company and its stakeholders.
- Need for standardization:
- 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, CMC content is currently authored and managed by industry in unstructured Word or PDF. This is not sustainable given the increasing volume and frequency of data exchanges. Not only are the authoring and updating 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 adverse events (AEs) back to the site of manufacture, and reusing the medicinal products composition in labelling.
- There is great value in ensuring industry’s CMC data exchange is transitioned to FHIR as other key areas of the medicinal product lifecycle are transitioning to FHIR and are already in the HL7 working group portfolio.
This project is being developed for FHIR R5. It will align with the PQ/CMC FHIR Implementation Guide (https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc/) where possible.
Project Insight Number
PSS-2137: Data exchange industry – Pharmaceutical Quality (Dxi-PQ)
PSS-2145: Data exchange industry – Pharmaceutical Quality (dX-PQ) PSS
CI Build: Data Exchange Industry – Pharmaceutical Quality (dx-PQ)
FHIR IG Proposal
Note, IG realm and code: uv / pharm-quality
Ballot Jira dashboard
TBD (Jira requires login)
9 & 10-Sep-23
HL7 Notification of Intent to Ballot (NIB) Approved & Submitted by BR&R
HL7 Workgroup (BR&R) review of IG for ballot (walk-through & 1 week to review)
HL7 Workgroup (BR&R) vote to approve IG for ballot
IG Complete and published for balloting
(22-Dec-23 - 22-Jan-24)
HL7 Ballot Period
(9-Jan-24 - 29-Feb-24)
FHIR Implementation Guide submitted to WG for publication approval
FHIR Implementation Guide approved for publication by WG (BR&R)
FHIR Implementation Guide approved for publication by FMG
FHIR Implementation Guide approved for publication by TSC
FHIR Implementation Guide published
- Craig Anderson <firstname.lastname@example.org>
- Mike Abernathy
- Rita Algorri
- Michael Banham
- Chris Jeschke
- Matt Willis
- Mike Vess
- Sheetal Gaiki
- Colin Wood
- Bill Gibson
- Caroline Hellawell
Lantana Consulting Group (IG developers)
- Kit Cooper, Project Manager <email@example.com>
- Rob Hausam, FHIR SME
- Rik Smitihies, CMC Regulatory SME
- Diana Wright, FHIR Analyst <firstname.lastname@example.org>
FHIR Resources (Draft)
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