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<p>This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products.</p>
<p>This document is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells.</p>
<p>This document does not cover the selection, assessment or control of starting materials and excipients.</p>
<p>NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.</p>
Reģistrācijas numurs (WIID)
67897
Darbības sfēra
<p>This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products.</p>
<p>This document is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells.</p>
<p>This document does not cover the selection, assessment or control of starting materials and excipients.</p>
<p>NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.</p>
