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About This Item

 

Full Description

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 20399-1
ISO 13485
ISO 9001


All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS ISO 20399:2022


    Biotechnology. Ancillary materials present during the production of cellular therapeutic products and gene therapy products

    • Most Recent
  2. BS PD ISO/TS 20399-1:2018


    Biotechnology. Ancillary materials present during the production of cellular therapeutic products-General requirements

    • Historical Version
  3. 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

    • Historical Version
  4. BS PD ISO/TS 20399-2:2018


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

    • Historical Version