ISO/PWI 20406

Biotechnology — Bioprocessing — Cell processing management system

Апстракт

This document specifies requirements for organizations to establish and maintain a cell processing management system for more consistent manufacturing of human cells for therapeutic use and meet the required specifications throughout the product lifecycle.
This document provides guidance on management principles, including planning, effective communication, system management, risk assessment and risk mitigation that supports establishing and maintaining critical quality attributes and critical process parameters.
This document will help effective communication among organization and facilitate technology transfer between organizations.
This document is primarily intended for organization manufacturing cells for therapeutic use, although concepts are applicable to earlier stage developers.
This document is not applicable to cells for food and feed products, agricultural or plant products.