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Pharmaceutical Quality - Chemistry, Manufacturing & Controls | PQ/CMC

PQ/CMC Recent Highlights

Stage 1 PQ/CMC FHIR Implementation Guide

The Stage 1 Implementation Guide (IG) for “Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA” passed ballot in May 2024 and work has completed working through the “reconciliation phase” of addressing all Ballot comments to update and improve the Implementation Guide.  The final step will be to go through the processes at HL7 to be allowed to published the Stage 1 IG which will have an official version, Standard for Trial Use (STU) v1.0.0. 

Stage 2 PQ/CMC Implementation Guide Testing at September 2024 HL7 Connectathon

Meanwhile, Stage 2 of the PQ/CMC FHIR Implementation Guide is being tested at the September 2024 HL7 FHIR Connectathon, September 21-22 in Atlanta, GA, USA.  The Stage 2 IG takes Stage 1 and adds support for new data content. The PQ/CMC Connectathon track information page has details on planned activities at the Connectathon. For those interested in participation at the September HL7 Connectathon, please see information at the registration site for the HL7 September Workgroup Meeting and HL7 FHIR Connectathon. (Early Bird registration fee ends on August 30th, 2024)

HL7 Connectathons are public 2-day sessions where creators of FHIR IGs, software creators/vendors, informatics folks, and experts gather to test an IG by generating test FHIR messages and running them through software to test FHIR validation and downstream data processing. Issues identified are used to revise and improve the IG before submitting it to ballot at HL7. 

Please note that HL7 Connectathon testing, balloting, and publication of interim versions of an IG does not represent the IG in a final form nor are these activities in any way a statement of policy or guidance from FDA."

Overview of the PQ/CMC Effort

As part of an effort intended to support future electronic acquisition and use of submitted information, FDA has undertaken a project to identify and prioritize pharmaceutical quality/chemistry, manufacturing and controls (PQ/CMC) information that would benefit from a structured submission approach. This structured and standardized information is intended to be submitted in the Module 3 of the Common Technical Document as defined by the International Council for Harmonisation’s (ICH) M4 Common Technical Document (CTD). The effort is scoped to some of what is currently submitted in Module 3 and Module 2.3 of the electronic Common Technical Document (eCTD) submission. It is not intended to be comprehensive in structuring all eCTD product quality information, only those concepts that were considered amenable to structuring and would bring value to the quality review process.

The goal of this project is to establish electronic standards for submitting Pharmaceutical Quality (PQ) and Chemistry & Manufacturing Controls (CMC) data.

Specific objectives of the PQ/CMC Project are:

  1. Develop structured data standards for PQ/CMC
  2. Develop a data exchange standard for submitting the structured PQ/CMC data to the FDA

The submission of structured data in a standardized format should increase the efficiency of FDA’s review of PQ/CMC data contained in the Module 3 of eCTD submissions for a New Drug Application (NDA), an Investigational New Drug Application (IND), a Biologics License Application (BLA), an Abbreviated New Drug Application (ANDA), a New Animal Drug Application (NADA), an Abbreviated New Animal Drug Application (ANADA), an Investigational New Animal Drug (INAD), Generic Investigational New Animal Drugs (JINADs), and a Master File (MF).

For consistency of product quality data across FDA centers, the draft standardized data elements and terminologies were created by an Agency workgroup comprised of Subject Matter Experts (SMEs) from the Center for Drug Evaluation and Research (CDER), the Center for Veterinary Medicine (CVM), and the Center for Biologics Evaluation and Research (CBER).

The PQ/CMC Data exchange standard is intended to be developed as Health Level 7 (HL7) Fast Health Interoperable Resources (FHIR) representation. The project has been established with the HL7 Biomedical Research & Regulation (BR&R) work group and discussions regarding representing the PQ/CMC structured elements in FHIR occur during the work group meetings. These HL7 BR&R WG meetings are open to the public.

PQ-CMC CTD Triangle Figure 1: ICH CTD Modules

Figure 1: ICH CTD Modules

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