Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

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 1.1.6 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

Example PackagedProductDefinition: Example Container Closure

Generated Narrative: PackagedProductDefinition 77ad6922-9c59-43d1-93cb-29d063cc2e8c

packageFor: Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000

description:

Plastic Bottle made of high-density polyethylene (HDPE). The plastic is chosen for its resistance to moisture and its ability to maintain the integrity of the drug.

Child-Resistant Cap: The cap features a Push-and-Turn Cap that he user to push down on the cap while turning it, which is difficult for children but manageable for adults.

attachedDocument: Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000

Packagings

-Type
*BOTTLE