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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

standard by BSI Group , 12/07/2018

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Full Description

BS PD ISO/TS 20399-2:2018 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.


Cross References:
ISO/TS 20399-1
PAS 84:2012
PAS 157:2015
ISO 13485
ICH Q6B
ICH Q7
FDA 1989
EP 5.2.12
ICH Q5E
ICH Q9
EP 2262
ISO 9001
ICH Q10


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

Product Details

Published:
12/07/2018
ISBN(s):
9780580942624
Number of Pages:
20
File Size:
1 file , 610 KB
Same As:
ISO/TS 20399-2:2018
Product Code(s):
30341522, 30341522, 30341522
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


    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

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

    • Historical Version