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

BSI Group , 12/07/2018

Publisher: BS

File Format: PDF

$95.00$190.50

Description

Standard By:BSI Group , 12/07/2018

Published:12/07/2018

Pages:20

ISBN(s):9780580942624

File Size:1 file , 610 KB

Language:English

Note:This product is unavailable in Ukraine, Russia, Belarus

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 20399-1PAS 84:2012PAS 157:2015ISO 13485ICH Q6BICH Q7FDA 1989EP 5.2.12ICH Q5EICH Q9EP 2262ISO 9001ICH Q10