Manufacturer inspections - product/process risk classifications

30 September 2016

Manufacturers of therapeutic goods are regularly inspected by the TGA using a risk-based approach to ensure compliance with manufacturing principles.

The emphasis and depth of manufacturer inspections, as well as the frequency of inspections are guided by the inherent risks of the product and the method of manufacture. Because some manufacturing sites use processes that involve much higher risks than others, the TGA classifies 'levels' of site risks as:

High risk

High risk products and processes include:

  • sterile medicines
  • sterile active pharmaceutical ingredients (APIs) manufactured under aseptic conditions
  • biotechnology APIs
  • single step sterilisers
  • primary collection, processing and storage sites for blood, including human haematopoietic stem cells (HPCs)
  • tissue banks and complex processing
  • cellular therapies
  • medical devices Class III and Active Implantable Medical Devices (AIMD).

Medium risk

Medium risk products and processes include:

  • APIs, to be used for sterile preparations not included in high risk category
  • registered non-sterile medicines, including registered herbal medicines, secondary blood collection and separation sites (including apheresis)
  • tissue banks with low manipulation
  • medical devices Class Is, IIa, IIb.

Low risk

Low risk products and processes include:

  • non-sterile APIs for registered medicines,
  • all listed medicines (including listed herbal medicines) sunscreens
  • medicinal gases
  • single step - labelling/packaging; analysis/testing; release for supply; storage
  • other (not primary or secondary) blood collection sites, including mobile units
  • medical devices Class I, IM (low risk medical devices).

Other

This category includes:

  • homoeopathic medicines
  • non-sterile APIs not included in a risk higher category