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Category
Standard
Version
6
Access
Open
Status
Active
Created
2021
This document outlines the standards that must be met by laboratories and other facilities involved in donor selection, collection, processing, storage and issue or disposal of directed minimally manipulated:

• haemopoietic progenitor cells (HPC)

• cord blood

• donor lymphocytes used for haemopoietic reconstitution

• donor lymphocytes issued for subsequent manufacture of a Therapeutic Goods Administration-approved product or under an approved clinical trial.

Main sections:

• Quality management

• Donor evaluation and selection

• Product collection

• Product processing

• Product testing

• Labelling

• Product storage

• Cellular product issue and distribution

• Transport and disposal

• Adverse events

• Health and safety
Access Requirements for procedures related to the collection, processing, storage and issue of human haemopoietic progenitor cells v6

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