Standards for Cellular Therapy Product Services

Beschreibung

The second edition of 'Standards for Cellular Therapy Product Services (CT Standards)' contains detailed requirements for HCT/P procurement, processing, storage, and release for administration. Organized according to the Core 10 quality template, the 'CT Standards' addresses operational aspects such as the determination of donor eligibility, product labeling, and other critical functions. The 'CT Standards' has been developed using an evidence-based decision process, and incorporates regulatory requirements as appropriate. New or expanded sections of this edition of 'CT Standards' include: - New requirements for monitoring of products during transportation - Revised reference standards on donor eligibility, and clinical and laboratory evaluation of donors - Requirements for notification of abnormal findings during clinical evaluation and laboratory testing of donors - References to regulatory resources

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Hematology Transfusion Medicine

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