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Background

Pharmaceutical Quality (PQ) or Pharmaceutical Quality/Chemistry, Manufacturing & Controls (PQ/CMC) is a term used to describe manufacturing and testing data of pharmaceutical products. PQ/CMC encompasses topics such as drug stability, quality specification, and batch analysis, which are important aspects of drug development. PQ/CMC plays an integral part in the regulatory review process and life cycle management of pharmaceutical products. This is a US Food & Drug Administration (FDA) sponsored project.  To learn more, visit

FDA PQ/CMC Page: https://www.fda.gov/industry/fda-data-standards-advisory-board/pharmaceutical-qualitychemistry-manufacturing-controls-pqcmc

Scope

  • Goal of this project is to establish electronic standards for submitting Pharmaceutical Quality (PQ)/Chemistry, Manufacturing & Controls (CMC) data that is part of the eCTD Module 3 data submission (as relevant).  The PQ/CMC effort is grouped in 2 Phases.
    • Phase 1 – includes development of data standards and data exchange standards for the following sub-domains within PQ/CMC: Drug Product, Drug Substance, Quality Specification, Batch Analysis and Stability.
    • Phase 2 - will include sub-domain such as, Manufacturing process for Drug Product and Drug Substance (API). Other sub-domains of Phase 2 are yet to be determined.

Project Status

  • ACTIVE  (Status Date: 10/2022)

UPDATE (4/21/22) –  US FDA has released a Federal Register Notice (FRN) soliciting comments on PQ/CMC Project data elements and its mapping and representation to FHIR Specifications. The comment period closes on May 17, 2022.

The Food and Drug Administration (FDA or Agency) is requesting comments on the draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange for the electronic submission of PQ/CMC data. The focus of this second FRN is to seek industry input on the FHIR mappings.

FRN: https://www.regulations.gov/document/FDA-2022-N-0297-0001


FHIR Resources (Draft)

Last Updated: `10/2022

The table below shows the FHIR domain Resources that are planned to be used in Phase 1 of the PQ/CMC Project.  This list may change a bit as we finalize the mappings to FHIR Resources. Phase 1 includes  – Drug Product, Drug Substance, Quality Specification, Batch Analysis and Stability.  The PQ/CMC Phase 1 requirements are represented in the FHIR Resources on https://build.fhir.org

As additional domains of CMC are structured, defined and represented in FHIR, the table below will be updated.








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