Biotechnology. Ancillary materials present during the production of cellular therapeutic products - Best practice guidance for ancillary material suppliers Ingestion-build-100998 ISBN 0 580 432661

ISBN 0 580 432661

BS EN ISO 8835-3:2009 + Amendment 1:2010

Equipment for which the electromagnetic compatibility requirements in the radio-frequencyrange are explicitly formulated in other IEC or CISPR standards

This document specifies requirements and test methods for divers’ watches and for saturation divers’ watches for use in deep diving (see Annex A which deals with watches for saturation diving)

This document specifies the informational structures

Biotechnology. Ancillary materials present during the production of cellular therapeutic products - Best practice guidance for ancillary material suppliers Ingestion-build-100998 ISBN 0 580 432661What is this standard about? This document provides guidance for ancillary material (AM) suppliers to maintain a high level of lot to lot consistency in the aspects of identity, purity, stability, biosafety, performance, as well as the accompanying documentation. This document is applicable to cellular therapeutic products, including gene therapy products whereby cells form part of the final product. It does not apply to products without cells. The