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Implementation of a Quality System; Australian Code of Good Manufacturing Practice‐Human Blood and Tissues
Author(s) -
Casey Peter,
Wake Beverley,
Canty Anne,
Hayward Allan,
Atkins Andrew
Publication year - 2005
Publication title -
transfusion medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.471
H-Index - 59
eISSN - 1365-3148
pISSN - 0958-7578
DOI - 10.1111/j.1365-3148.2005.00554bb.x
Subject(s) - medicine , apheresis , agency (philosophy) , quality (philosophy) , clinical practice , intensive care medicine , business , medical emergency , nursing , philosophy , platelet , epistemology
The Haematology Day Centre (HDC), Royal Adelaide Hospital (RAH) is the contracted facility for supply of Peripheral Blood Stem Cells (PBSC), for Autologous and Allogeneic Transplantation by Apheresis to the Therapeutic Product Facility (TPF), Institute of Medical and Veterinary Science (IMVS). The IMVS was working towards compliance for Code of Good Manufacturing Practice (cGMP), Human Blood and Tissues for their Processing and Cryopreservation Facility and had submitted an application for licence in 2000 to the regulatory agency, Therapeutic Goods Administration. The HDC began formalising processes towards compliance to the cGMP in November 2001. The collection process of PBSC is integral to successful licensure for cGMP which was obtained by the IMVS in July 2003. This process was as much about change management, as fi nding solutions to practical issues relating to cGMP within an area of diverse clinical practice. The HDC experience is discussed in relation to fundamental change management and practical issues implementing quality systems within and across two organisations.