Australian code of good manufacturing practice for medicinal products

The Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002), replaces the Australian Code of Good Manufacturing Practice for Therapeutic Goods – Medicinal Products (August 1990), the Australian Code of Good Manufacturing Practice for Therapeutic Goods – Medicinal Gases (July 1992) and the Investigational Medicinal Products Code of GMP (Annex 13, EC GMP Guide, 1997).

The new Code is based entirely on the international standard entitled Guide to Good Manufacturing Practices for Medicinal Products, version PH 1/97 (Rev. 3), 15 January 2002, published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The modifications to that Guide and its adoption as the Australian Code of Good Manufacturing Practice, is done so with the expressed permission of the PIC/S.

The Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002) was fully implemented on 21 August 2003 after a 12 month transition period and is the basis for licensing all Australian manufacturers of medicinal products.