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About This Item
Full Description
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.
Document History
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BS ISO 20399:2022
Biotechnology. Ancillary materials present during the production of cellular therapeutic products and gene therapy products- Most Recent
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BS PD ISO/TS 20399-1:2018
Biotechnology. Ancillary materials present during the production of cellular therapeutic products-General requirements- Historical Version
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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
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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