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Consultation: Compounded medicines and good manufacturing practice (GMP)

30 September 2020

This consultation closed on 18 December 2020.

The Therapeutic Goods Administration’s Manufacturing Quality Branch (MQB) regulates the manufacture of therapeutic goods, including goods that are extemporaneous compounded, dispensed or repackaged. The current guidance for manufacturers in this sector was published in 2017 following targeted industry consultation and outlines an acceptable.

Following updates to the Manufacturing Principles in July 2020, and the receipt of feedback regarding opportunities for improvement, the MQB has produced a draft of updated guidance and we have issued this consultation to seek input from stakeholders.

This draft guidance paper includes proposed enhancements to the interpretation of current GMP requirements specified in the PIC/S Guide to GMP, PE009, specifically in relation to:

  • The allocation of expiry dates for compounded goods.
  • Expiry dating of compounded goods manufactured from biological medicines, e.g. monoclonal antibodies.
  • The manufacture of non-sterile goods and re-packaged goods in dose administration aids (DAA)

We invite you to review the consultation paper and provide a response using the response template, accessible through our Consultation Hub.