S/HL7/FHIR-R5/US/PQ-CMC

Health Level Seven International®, or HL7®, is a nonprofit organization developing and maintaining healthcare technology related standards [1]^,[2]. HL7 Fast Healthcare Interoperability Resources, or HL7 FHIR®, is “a standard for exchanging healthcare information electronically”. The FHIR includes multiple components arranged in 5 levels to support healthcare data recording, maintaining, and exchanging [3].

A “resource” in FHIR is defined as a data block with specified representing format and metadata [4]. By building resource blocks, the standard can combine blocks and be utilized for precise information processing across systems. There are multiple formats available for FHIR resource definition [5].

FDA released draft structured data standard supporting electronic submission of information related to Pharmaceutical Quality/Chemistry, Manufacturing and Controls (PQ/CMC). The standard is intended for “concepts that were considered amenable to structuring and would bring value to the quality review process” [6]^,[7]^,[8]. Project level information and structure are available in PQ-CMC IG [9]^,[10].

Reference

---

[1]

HL7. (year). HL7. (web page)

[2]

HL7. (year). HL7 Essentials. (web page)

[3]

HL7. (year). HL7 FHIR. (web page)

[4]

HL7. (year). HL7 FHIR Base Resource Definitions. (web page)

[5]

HL7. (year). HL7 FHIR Resource Formats. (web page)

[6]

FDA. (2017). Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies; Request for Comments. (web page)

[7]

FDA. (2022). Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange. (web page)

[8]

FDA. (2024). Pharmaceutical Quality - Chemistry, Manufacturing & Controls | PQ/CMC. (web page)

[9]

HL7. (2024). Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA IG. (web page)

[10]

HL7. (2024). Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA IG. (github)