Revised code of GMP for human blood and biologicals

4 July 2016

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 commenced 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 commenced on 31 May 2013, the same time as TGO 88, with a 12 month transition period applied.

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