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<p>This document provides general requirements for the testing of cellular therapeutic products intended for human use.</p>
<p>This document also provides considerations for the characterization of cellular therapeutic products, including approaches to select and design analytical methods that are fit for purpose.</p>
<p>Such considerations can be used to establish critical quality attributes for a cellular therapeutic product.</p>
<p>This document is applicable to cellular starting materials (including those for tissue engineered products) and intermediates of cellular therapeutic products.</p>
<p>This document is not applicable to tissues used in transplantation.</p>
Reģistrācijas numurs (WIID)
74367
Darbības sfēra
<p>This document provides general requirements for the testing of cellular therapeutic products intended for human use.</p>
<p>This document also provides considerations for the characterization of cellular therapeutic products, including approaches to select and design analytical methods that are fit for purpose.</p>
<p>Such considerations can be used to establish critical quality attributes for a cellular therapeutic product.</p>
<p>This document is applicable to cellular starting materials (including those for tissue engineered products) and intermediates of cellular therapeutic products.</p>
<p>This document is not applicable to tissues used in transplantation.</p>
