Revised code of GMP for human blood and tissues

4 June 2013

Manufacturers of blood, blood components, tissues and cellular therapy products, including biologicals, must meet the requirements of the Manufacturing Principles (unless exempt).

The Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013 references the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products 2013 (2013 Code of GMP). These requirements commence from 31 May 2013.

The 2013 Code of GMP removes product specific requirements including those relating to minimisation of infectious disease transmission. These requirements are specified in a new standard: Therapeutic Goods Order No. 88 - Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products (TGO 88).

Transition

The 2013 Code of GMP commences on 31 May 2013, the same time as TGO 88. A 12 month transition period applies to both the 2013 Code of GMP and to TGO 88.

Manufacturers of human blood, blood components, human tissues and cellular therapy products who wish to do so can begin complying with the 2013 Code of GMP before the 12 month transition period ends (the end of that period being 31 May 2014).

However, if sponsors and manufacturers wish to begin complying with the 2013 Code of GMP before the compliance date, they must also ensure that the revised TGO 88 is or has been observed in the manufacture of their goods, as these are intended to apply together.

Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products 2013