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Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) (PSS in Confluence)

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Basics

Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) (PSS in Confluence)

1537
Ballot - STU to Normative


FHIR Implementation Guide; FHIR Profile

Create New Standard, Implementation Guide, Externally developed IG is to be Endorsed

Details

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. Currently the baseline requirements are specific to the US, but this may expand to be global.


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.



Two objectives: 1. To standardize the product 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 Quality Specification Profile--January 2020 Ballot


https://confluence.hl7.org/display/BRR/Pharmaceutical+Quality+%28PQ%29+PSS HL7 Github - https://github.com/HL7/FHIR-pq-cmc

US FDA

Some FHIR Resources that are needed for PQ/CMC are owned by other HL7 WG, such as PlanDefinition, Observation, Specimen, etc. Dependency on the some IDMP Resources too. Will need to coordinate activities.

Regulatory Agency, Standards Development Organizations (SDOs), Other (specify in Misc. Notes below)

US FDA, 6 Pharmaceutical companies implementing a proof-of-concept




Yes


No

2025 July: TSC approved an STU Publication Request for HL7 FHIR® Implementation Guide: Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) Submissions to FDA, Edition 2 - US Realm for 2 years 2024 December: TSC approved STU Publication Request for HL7 FHIR Implementation Guide: Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) Submissions to FDA, Edition 1- US Realm for 2 years This project replaces project 1368. Other Stakeholders: Pharmaceutical Industry, Testing Facilities/ CRO, Manufacturing entities Other Vendors: LIMS vendors
Organization & Realm

Realm Specific - Enter "U.S." or name of HL7 Affiliate below

U.S.
People

Mary Ann Slack; Boris Brodsky



Biomedical Research and Regulation Work Group


Status & Dates

Active

STU - Test Period/Accepting Comments

05/21/2019

01/01/2027

2027 Jan WGM/Ballot

01/01/2027

2027 Jan WGM/Ballot

2025 Jan Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 2 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) Submissions to FDA, Edition 2- US Realm 2024 May Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 3 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) Submissions to FDA, Edition 1- US Realm
Approvals

06/18/2021


Received


All Received




System Info



View Ballot Items (with NIBs)




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