AUSTRALIA'S TGA POSTS UPDATED GMP GUIDELINES

The Australian Therapeutic Goods Administration (TGA) has posted on its website updated guidelines on good manufacturing practice (GMP) clearance for drug manufacturers outside of Australia. The document also includes guidelines specifically aimed at overseas makers of active pharmaceutical ingredients.

The document is intended to provide information on what TGA regards as an acceptable form of evidence of GMP compliance and as guidance for sponsors and manufacturers on how to submit that evidence for assessment. It is not intended to provide a definitive list of forms of evidence that are considered acceptable or unacceptable, according to the agency.

Overseas manufacturers must comply with the same requirements of current GMPs as those expected of licensed Australian manufacturers. The TGA also notes that it reserves the right to conduct an audit of any overseas manufacturer.

To view the updated guidelines, go to www.tga.gov.au/manuf/gmpsom.htm (http://www.tga.gov.au/manuf/gmpsom.htm).