Good manufacturing practice Australia

Manufacturing sites within Australia must comply with the Australian Code of GMP for Medicinal Products - August 2002, which is based entirely on the international standard Guide to Good Manufacturing Practices for Medicinal Products, Version PHl/97 (Rev.3) 15 January 2002, published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The ICH GMP Guide for Active Pharmaceutical Ingredients has also been adopted. 

Good Manufacturing Practice (GMP) EEC, Japan, USA (FDA, formally not USDA), in Australia expected by 1994/1995. 

The potential formation of chlorine dioxide is considered limited and in any case does not exceed 1-3 mg/l (United States Department of Agriculture, 2002 Food Safety Australia New Zealand, 2003 European Food Safety Authority, 2005 Ecolab Inc., 2006). Although levels of chlorine dioxide have been shown to increase during solution ageing, chlorine dioxide is a very volatile compound and is considered not to be present as a residue of the treated food product if ASC from a spray or a dip solution is used according to good manufacturing practices (Ecolab Inc., 2006). 

Rope has been and still is, a worldwide problem in bread, especially in countries where the climate is warm such as Australia, parts of Africa and India, and in some cases where the standards of hygiene and the enforcement of good manufacturing practices are poor. 

A Code of GMP was introduced in the late 1960s, covering principles and practices to be followed in the manufacture of therapeutic goods in Australia, but still relied upon State legislation and personnel for its enforcement. 

---