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1a. Project Name

Pharmaceutical Quality (PQ)

1b. Project ID


1c. Is Your Project an Investigative Project (aka PSS-Lite)?


1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?


1e. Today's Date

1f. Name of standard being reaffirmed

1g. Project Artifact Information

1h. ISO/IEC Standard to Adopt

1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?

1j. Unit of Measure

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Mary Ann Slack; Boris Brodsky

2e. Other Interested Parties (and roles)

European Medicines Agency (EMA)

2f. Modeling Facilitator


2g. Publishing Facilitator


2h. Vocabulary Facilitator

Norman Gregory

2i. Domain Expert Representative

FDA Reviewers: Norman Schmuff, Norman Gregory, Frank Holcombe, Michael Kerrigan

2j. Business Requirements Analyst

Smita Hastak, Catherine-Hosage Norman

2k. Conformance Facilitator

Catherine Hosage-Norman

2l. Other Facilitators

Lloyd McKenzie

2m. Implementers

US FDA, 5 Pharmaceutical companies implementing a proof-of-concept.

3a. Project Scope

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


3b. Project Need

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.

3c. Security Risk


3d. External Drivers


3e. Objectives/Deliverables and Target Dates

Two objectives: 1. To standardize the pharamaceutical 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

3f. Common Names / Keywords / Aliases:

Pharmaceutical Quality, Drug Quality, CMC, Product Quality

3g. Lineage


3h. Project Dependencies

Some FHIR Resources that are needed for PQ/CMC are owned by other HL7 WG, such as PlanDefinition, Observation, Specimen, etc.
Dependency on some BR&R IDMP Resources too. Working closely with IDMP resource developers and providing input and PQ requirements. Adding tacker items for requirements to resources from other WGs.

3i. HL7-Managed Project Document Repository URL:

3j. Backwards Compatibility


3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?


3l. Reason for not using current V3 data types?

Using FHIR Data types

3m. External Vocabularies


3n. List of Vocabularies

NCI EVS, UCUM, FDA SRS Listing System (UNII), CAS Number, INN, IUPAC

3o. Earliest prior release and/or version to which the compatibility applies


4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

FHIR 4.0

4c. FHIR Profiles Version


4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Create new standard, Implementation Guide (IG) will be created/modified

5a. White Paper Type

5a. Is the project adopting/endorsing an externally developed IG?


5a. Externally developed IG is to be (select one)

5a. Specify external organization

5a. Revising Current Standard Info

5b. Project Ballot Type

STU to Normative

5c. Additional Ballot Info

Plan to do a phased approach for balloting. The entire PQ/CMC domain will most likely support multiple profiles. Plan is to ballot the first profile with PQ/CMC FHIR IG and then include additional profiles and build on the existing PQ/CMC IG in subsequent ballots..

5d. Joint Copyright


5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.


6a. External Project Collaboration


6b. Content Already Developed

90% of the domain content was developed by FDA with substantial feedback from the Pharamaceutical industry.; 30% FHIR resources mapping identified. Work-in-progress to identify gaps in existing resources. Coordinating with BR&R and other WGs.

6c. Content externally developed?


6d. List Developers of Externally Developed Content


6e. Is this a hosted (externally funded) project?


6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs), Other

6f. Other Stakeholders

Pharmaceutical Industry, Testing Facilities/ CRO, Drug Manufacturing entities

6g. Vendors

Pharmaceutical, Other

6g. Other Vendors

LIMS vendors

6h. Providers


6h. Other Providers

6i. Realm

U.S. Realm Specific

7d. US Realm Approval Date

Jun 04, 2019

7a. Management Group(s) to Review PSS


7b. Sponsoring WG Approval Date

May 21, 2019

7c. Co-Sponsor Approval Date

7c. Co-Sponsor 2 Approval Date

7c. Co-Sponsor 3 Approval Date

7c. Co-Sponsor 4 Approval Date

7c. Co-Sponsor 5 Approval Date

7c. Co-Sponsor 6 Approval Date

7c. Co-Sponsor 7 Approval Date

7c. Co-Sponsor 8 Approval Date

7c. Co-Sponsor 9 Approval Date

7c. Co-Sponsor 10 Approval Date

7e. CDA MG Approval Date

7f. FMG Approval Date

May 22, 2019

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

7j. TSC Approval Date

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1 Comment

  1. With so much externally developed content this will require ARB review before it can be approved by the TSC. The name of the project should be more informative than a couple of acronym's. The Pharmacy work group should be approached as a co-sponsor of this project.