ISO/NP 25076

Principles for production of cell cultured products ISO/NP 25076

Scope

This document provides a benchmark for evaluation of the design, operation and performance of cell cultured products practices and systems.
This document is applicable to the design of new production systems.
This document is applicable only to the upstream and midstream production processes.
This document covers the following topics:
— principles of cell cultured production process systems;
— process design, construction, operation and maintenance of cell cultured production systems;
— controlling cell cultured systems parameters.

This document does not cover the following topics:

— downstream processes;
— packaging, labelling, storage and distribution;
— validation;
— Quality assurance (QA/QC);
— Sustainability;
— safety and hazards;
— Production area/Clean rooms.

NOTE It is important to note that cell cultured is a rapidly evolving field, and specific principles and techniques may vary depending on the specific product being cultivated and the technological advancements at any given time.