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Protocol for the validation of microbiological control of cellular products according to German regulators recommendations – Boon and Bane for the manufacturer
Author(s) -
Störmer M.,
Radojska S.,
Hos N. J.,
Gathof B. S.
Publication year - 2015
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1111/vox.12222
Subject(s) - protocol (science) , control (management) , german , computer science , process validation , reliability engineering , microbiology and biotechnology , biochemical engineering , medicine , biology , engineering , operations management , verification and validation , artificial intelligence , pathology , alternative medicine , archaeology , history
In order to generate standardized conditions for the microbiological control of HPC s, the PEI recommended defined steps for validation that will lead to extensive validation as shown in this study, where a possible validation principle for the microbiological control of allogeneic SCP s is presented. Although it could be demonstrated that automated culture improves microbial safety of cellular products, the requirement for extensive validation studies needs to be considered.