Standards and Guidelines

FACT-JACIE Common Standards for Cellular Therapy represent the basic fundamentals of cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials. The Common Standards can be used to improve cellular therapy programs utilizing non-hematopoietic cells or treating non-hematological diseases.

The EU Directive 2004/23/EC lays down quality and safety standards to minimise the risk of infection and prevent transmission of disease when transplanting human tissues and cells.

It covers the entire chain of activities: from donation to procurement, testing, processing, preservation, storage and distribution to the site of medical use or to sites where manufactured products are made from these human substances.

The EU Regulation 1394/2007 and amending  Directive 2001/83/EC on Advanced Therapy Medicinal Products contain rules for authorisation, supervision and technical requirements regarding the summary of product characteristics, labeling and package leaflet of ATMP's.

ISBT 128 is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products).

ISO 14644 is the global standard that covers the requirements of clean rooms and other controlled environments.