TGA Clearance applications for overseas manufacturers are now required to be submitted along with a GMP Agreement detailing arrangements between the sponsor and manufacturer. The TGA has indicated that in addition to the normal scope of GMP Agreements, specific areas that are often omitted and required to be included in the GMP Agreement are:

  • responsibilities for change control,
  • deviation management,
  • equipment validation,
  • and title and risk of goods.

An additional requirement particularly relevant for products being shipped from overseas manufacturers to sponsors, or for products being transported long distances in Australia from manufacturers to sponsors is for the responsibility for temperature data loggers to be defined. As such, it is recommended that current GMP Agreements between sponsors and manufacturers are updated to reflect the scope expected by the TGA Manufacturing Quali