Overview

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.

Background

  • 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.

Scope

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 Information

Project Insight Number

1800  

Project Proposal    

PSS-2137: Data exchange industry – Pharmaceutical Quality (Dxi-PQ)
Accepted 2022-12-06

PSS

PSS-2145: Data exchange industry – Pharmaceutical Quality (dX-PQ) PSS
Approved 2023-02-06

GitHub

https://github.com/HL7/uv-dx-pq

CI Build: Data Exchange Industry – Pharmaceutical Quality (dx-PQ)

https://build.fhir.org/ig/HL7/uv-dx-pq/

FHIR IG Proposal

Data Exchange for Industry – Pharmaceutical Quality (dx-PQ)

Note, IG realm and code: uv / pharm-quality

Connectathon information

2023 - 09 dx-PQ IG: Data Exchange Industry – Pharmaceutical Quality

Ballot

JAN2024

Ballot Jira dashboard

TBD (Jira requires login)

Project Status

TIMELINE

Date (estimated)

Milestone

Status

12-Dec-22

HL7 Project Scope Statement Submitted

Complete

13-Dec-22

HL7 Project Scope Statement Approved by the WG

Complete

10-Jan-23

HL7 Project Scope Statement Approved by the TSMG (we are using external terminology)

Complete

11-Jan-23

HL7 Project Scope Statement Approved by the FMG

Complete

6-Feb-23

HL7 Project Scope Statement Approved by the TSC eVote and 2023-02-06 TSC Agenda/Minutes

Complete

2-May-23

HL7 Project Confluence Page Created

Complete

3-Jul-23

HL7 FHIR Connectathon Proposal Submitted

Complete

9 & 10-Sep-23

HL7 FHIR Connectathon 34

Complete

18-Oct-23

FHIR Implementation Guide Proposal submitted to FMG & approved

Complete

7-Nov-23

HL7 Notification of Intent to Ballot (NIB) Approved & Submitted by BR&R

Complete

(5-Dec-23)

HL7 Workgroup (BR&R) review of IG for ballot (walk-through & 1 week to review)

Planned

(12-Dec-23)

HL7 Workgroup (BR&R) vote to approve IG for ballot

Planned

(17-Dec-23)

IG Complete and published for balloting

Planned

(22-Dec-23 - 22-Jan-24)

HL7 Ballot Period

Planned

(9-Jan-24 - 29-Feb-24)

Ballot Reconciliation

Planned

(1-Apr-24)

FHIR Implementation Guide submitted to WG for publication approval

Planned

(9-Apr-24)

FHIR Implementation Guide approved for publication by WG (BR&R)

Planned

(18-Apr-24)

FHIR Implementation Guide approved for publication by FMG

Planned

(25-Apr-24)

FHIR Implementation Guide approved for publication by TSC

Planned

(30-Apr-24)

FHIR Implementation Guide published

Planned


Project Team

Accumulus Synergy

  • Craig Anderson <craig.anderson2@pfizer.com>
  • 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 <kit.cooper@lantanagroup.com>
  • Rob Hausam, FHIR SME
  • Rik Smitihies, CMC Regulatory SME
  • Diana Wright, FHIR Analyst <diana.wright@lantanagroup.com>

Industry Members

  • Amgen
  • Astellas
  • AstraZeneca
  • BMS
  • GSK
  • J&J
  • Lilly
  • Merck
  • Pfizer
  • Roche
  • Sanofi
  • Takeda

FHIR Resources (Draft)

Last Updated: `










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