Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

## Change Notes

Page standards status: Informative

### Version = 2.0.0

Publication Date: 2025-04-TBD url: http://hl7.org/fhir/us/pq-cmc-fda/STU2 Based on FHIR version : 5.0.0

#### Additions:

The 2025 January Ballot, Version 2.0.0-ballot of the HL7 FHIR Implementation Guide (IG) for Pharmaceutical Quality - Chemistry, Manufacturing, and Controls (PQ-CMC) Submissions to the FDA introduces several Bundle profiles to structure and standardize the submission data. Each Bundle profile serves a specific purpose in organizing related information:​

1. Substance Characterization Bundle: This Bundle captures detailed information about the drug substance, including its identity, physicochemical properties, and manufacturing process. It ensures that all relevant data about the substance are cohesively presented, facilitating comprehensive evaluation.​

2. Product Batch Formula Bundle: This Bundle details the composition of a specific batch of the drug product, including quantities of each component and any variations from the standard formula. It provides a clear representation of the batch's formulation, supporting consistency and quality assessments.​

3. Product Characterization of Impurities Bundle: This Bundle focuses on identifying and quantifying impurities present in the drug product. It includes information on impurity profiles, potential sources, and control strategies, ensuring that impurity data are systematically organized for regulatory review.​

These Bundles collectively enhance the IG's capability to standardize PQ-CMC submissions, promoting structured data exchange between industry stakeholders and the FDA.

#### Changes:

The ballot-related comments resulted in changes to this specification, which are listed below:

Tracker Status: (Change Category) Summary Jira Issue Link to Updated Content

1. Applied: (Correction) Update Narrative Transform for 32P32 FHIR-49251 See Changes Here
2. Applied: (Correction) Update code and display in Batch Formula to align with ICH FHIR-49294 See Changes Here
3. Applied: (Correction) Update CTD code and display in Product Characterisation of Impurities to align with ICH FHIR-49295 See Changes Here
4. Applied: (Clarification) Arrow missing in the CTD 3.2.S.3 Profile Map FHIR-49298 See Changes Here
5. Applied: (Clarification) Add 2 more acknowledgements in the Credits section on the Home page FHIR-49328 See Changes Here
6. Applied: (Clarification) Add a clarification sentence in Batch Formula profile to mention single layer tablets use also. FHIR-49330 See Changes Here
7. Applied: (Clarification) In Batch Formula profile Domain Overview provide an explanation for terms of Components and Constituents by referring to the 32P1 FHIR-49331 See Changes Here
8. Applied: (Correction) Change name of CTD Section 3.2.S.3.1 in Substance Characterisation FHIR-49352 See Changes Here
9. Applied: (Clarification) Remove example images from General Instructions FHIR-49420 See Changes Here
10. Applied: (Clarification) In Artifacts page under Example section, replace the OID names with human readable terms and standardize the names FHIR-49421 See Changes Here
11. Applied: (Correction) Change Notes/Log incomplete FHIR-49574 See Changes Here
12. Applied: (Clarification) Update text on Home page under section 1.3 IG Overview FHIR-49594 See Changes Here
13. Applied: (Clarification) Update ALL Profile Map diagrams in the IG. Change the label from "Reference" to "Page". FHIR-49596 See Changes Here
14. Applied: (Clarification) Change unit of "1*" to other unit in example FHIR-49621 See Changes Here
15. Applied: (Correction) Overage extension modified with name changes, and invariant FHIR-49622 See Changes Here
16. Applied: (Correction) Update Home page - Section 1.2.1 IG Scope FHIR-49285 See Changes Here
17. Applied: (Correction) Labels in the Narrative Transform too FHIR oriented FHIR-49574 See Changes Here

### Version = 1.0.0

Publication Date: 2024-12-11 url: http://hl7.org/fhir/us/pq-cmc-fda/STU1 Based on FHIR version : 5.0.0

#### Changes:

The first official published version of this IG published as FHIR STU1.