BS PD ISO/TS 20399-3:2018 provides guidance for ancillary material (AM) users. It is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells.Cross References:ISO/TS 20399-1ISO 13485ISO 9001
BS PD ISO/TS 20399-3:2018
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Biotechnology. Ancillary materials present during the production of cellular therapeutic products-Best practice guidance for ancillary material users
BSI Group , 12/07/2018
Pages: 20
