Committee Draft
ISO/CD 20399-4
Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products — Part 4: Requirements for the certificate of analysis and the certificate of origin
Reference number
ISO/CD 20399-4
Edition 1
© ISO 2026
Committee Draft
Under development
A draft is being reviewed by the committee.

Abstract

This document specifies definitions and general requirements for developing and reporting a certificate of analysis (CoA) and a certificate of origin (CoO) for ancillary materials (AMs) used in manufacturing of cellular therapeutic products and gene therapy products.

This document includes minimum requirements for ancillary material CoA and CoO reporting and management.

This document is applicable to AM suppliers and AM users, i.e., manufacturers of cell and gene products.

General information

  • Status
     : Under development
    Stage
    : Close of comment period [30.60]
  • Edition
     : 1
  • Technical Committee :
    ISO/TC 276
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

3
Good Health and Well-being
8
Decent Work and Economic Growth
9
Industry, Innovation and Infrastructure

Got a question?

Check out our Help and Support

  2. Store
  3. Store
  4. ICS
  5. ISO/CD 20399-4