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<p>This document specifies definitions and general requirements for developing and reporting a certificate of analysis (CoA) and a certificate of origin (CoO) for ancillary materials (AMs) used in manufacturing of cellular therapeutic products and gene therapy products.</p>
<p>This document includes minimum requirements for ancillary material CoA and CoO reporting and management.</p>
<p>This document is applicable to AM suppliers and AM users, i.e., manufacturers of cell and gene products.</p>
Reģistrācijas numurs (WIID)
92505
Darbības sfēra
<p>This document specifies definitions and general requirements for developing and reporting a certificate of analysis (CoA) and a certificate of origin (CoO) for ancillary materials (AMs) used in manufacturing of cellular therapeutic products and gene therapy products.</p>
<p>This document includes minimum requirements for ancillary material CoA and CoO reporting and management.</p>
<p>This document is applicable to AM suppliers and AM users, i.e., manufacturers of cell and gene products.</p>
