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
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.
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