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 ISO/CD 20399-4

Scope

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.