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BS PD ISO/TS 20399-1:2018

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

standard by BSI Group , 02/06/2019

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Full Description

BS PD ISO/TS 20399-1:2018 specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products.


Cross References:
ISO 10993-12:2012
ISO Guide 30:2015
PAS 84:2012
ICH Q3D
ISO 13022
ICH Q7
ISO 9001
ISO 13485
ICH Q3B


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

Product Details

Published:
02/06/2019
ISBN(s):
9780580942471
Number of Pages:
20
File Size:
1 file , 700 KB
Same As:
ISO/TS 20399-1:2018
Product Code(s):
30341478, 30341478, 30341478
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

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

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

    • Historical Version

  3. BS PD ISO/TS 20399-3:2018


    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