Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Best Practices, Resources

User Interface

The developers of this guide recommend that user interface applications implementing this specification include alternative text descriptions of images and other accessibility standards, such as those described in:

• U.S. General Services Administration (GSA), https://www.section508.gov/
• W3C, Web Content Accessibility Guidelines (WCAG), https://www.w3.org/TR/WCAG21/ (or latest version)

References

• Common Technical Document (CTD) structure:
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH Harmonised Tripartite Guideline: The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality –M4Q(R1); Module 3: Quality (12 September 2002) https://database.ich.org/sites/default/files/M4Q_R1_Guideline.pdf
• Content for requirements specified in this implementation guide:
  • ICH, Quality Guidelines, https://www.ich.org/page/quality-guidelines
  • ISO standards listed on https://www.iso.org/news/ref2234.html
• Global Substance Registration System (G-SRS)