The Requirements for Procedures Related to the Collection, Processing, Storage and Issue of Human Haemopoietic Progenitor Cells (Sixth Edition 2021) is a revision of the 2015 edition and sets out the minimum standards for facilities involved in donor selection, collection, processing, storage or disposal of directed minimally manipulated:

• haemopoietic progenitor cells (HPC)
• cord blood; and
• donor lymphocytes which are used for haemopoietic reconstitution; and
• donor lymphocytes which are issued for subsequent manufacture of a TGA approved product or under an approved clinical trial.

The scope of the Requirements to include donor lymphocytes used for haemopoietic reconstitution and donor lymphocytes which are issued for manufacture of a TGA approved product or under an approved clinical trial.

This document has a proposed date of effect of 1 January 2022.

• Requirements for Procedures Related to the Collection, Processing, Storage and Issue of Human Haemopoietic Progenitor Cells (Sixth Edition 2021) (PDF 1806 KB)
• Requirements for Procedures Related to the Collection, Processing, Storage and Issue of Human Haemopoietic Progenitor Cells (Sixth Edition 2021) (Word 99 KB)