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

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 cell and gene therapy products (excluding single use components).

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

This document is applicable to ancillary materials used in cell and gene therapy product manufacturing (e.g., cell culture media and its components, cytokines used in cell expansion, reagents used in vector manufacturing, etc.).

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

NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.