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
Latest News: On May 1, 2023, FDA published a federal register notice including a document of new PQ/CMC data elements and terminologies for public comment. FDA is only seeking comment on Chapter 2 of the associated document. Comments on Chapter 1 will not be addressed as that content was published for comment previously in March 2022. Click to view the notice and associated document. You may also download the new document directly from fda.gov by clicking this link.
NOTE: FDA refers to this project as Pharmaceutical Quality/Chemistry, Manufacturing & Controls (PQ/CMC) & at HL7 it is called Pharmaceutical Quality (PQ)
- 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) to the Food and Drug Administration (FDA). 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.
- ACTIVE (Status Date: 04/2023)
PQ/CMC Project has been developing an Implementation Guide that is scoped to Phase 1. It is work-in-progress and continues to evolve as new Profiles and examples are added to cover the Phase 1 scope.
Pharmaceutical Quality FHIR IG – https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc/
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.