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

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

ISBN 0 580 432661

The immunity requirements have been selected to ensure an adequate level of immunity for apparatus at residential

It provides specific principles and requirements for the assessment of economic performance of buildings taking into account technical characteristics and functionality of a building

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

Medical gloves for single use

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)

Aggregate particles are classified as elongated when they have a length (greatest dimension) of more than 1

Abel closed-cup method

This document specifies the informational structures

The information consists of a variety of mandatory and optional items

and magnetization

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