DANSK DSF/ISO/DIS 20399 PDF

This document provides guidance to suppliers and users of ancillary materials to improve the consistency and quality of ancillary materials of biological (human and animal) and chemical origin used in the production of  cellular therapeutic products and gene therapy products for human use. This document is intended to help the suppliers and users of ancillary materials to achieve and maintain an appropriate level of documented lot-to-lot consistency in the aspects of identity, purity, storage and stability, biosafety, and performance. This document provides guidance to ensure the quality of AMs will lead to final products that are safe and effective. Cells that are either starting materials, final therapeutic products, or both are not within scope. For clarity, feeder cells, apparatus and instruments, or additives used post bioprocessing are not within scope. NOTE 1 – A decision chart that indicates whether or not a material is in scope of this document is described in Annex A.NOTE 2 International, regional, or national regulations or requirements can also apply to specific topics covered in this document.”