Planned Update to Manufacturing Principles for medicines, APIs and sunscreens

Australia’s current Manufacturing Principles for the manufacture of medicines, active pharmaceutical ingredients and sunscreens is the PIC/S Guide to Good Manufacturing Practice (GMP) – 1 February 2022, PE009-16, except for its Annexes 4, 5, and 14. This version of the PIC/S Guide was adopted on 3 June 2024.

This notification is to advise we are moving to a more recent version and will be adopting the PIC/S Guide to GMP – 25 August 2023, PE009-17, except for Annexes 4, 5 and 14 on 1 September 2025. 

What are the main changes?

The changes in version 17 relate only to Annex 1.

Annex 1 – This annex has been amended and contains information and requirements related to the manufacture of sterile medicinal products.

How will the new Guide to GMP be adopted?

The adoption of the PIC/S Guide to GMP – 25 August 2023, PE009-17 is planned to commence on 1 September 2025 from which point GMP inspectors will use the new Guide to GMP during inspections. Compliance with the basic requirements of the PIC/S Guide to GMP – 25 August 2023, PE009-17 will be expected from the date of adoption. 

For manufacturers of sterile medicines, we do not expect all manufacturers to have data immediately available to meet some of the new requirements. As a result, a phased approach is being taken to assessing compliance with these items during our on-site inspections. 

We have held industry consultations over the past year and will continue to work with industry to develop further interpretative guidance where required. 

We will update existing guidance on the interpretation on the PIC/S Guide to GMP, to reflect changes introduced by the adoption of PE00-17 - 25 August 2023.

What actions do manufacturers need to take now?

Manufacturers are encouraged to review the PIC/S Guide to GMP – 25 August 2023, PE009-17 and ensure you are familiar with the requirements relevant to your manufacturing operations.

The PIC/S Guide to GMP for medicinal products – version 17

From 1 September 2025 the PIC/S Guide to GMP – 25 August 2023, PE009-17 will apply to the manufacture of medicines, active pharmaceutical ingredients and sunscreens, unless exempt under provisions in the Therapeutic Goods Act 1989 (the Act). 

The Guide is divided into two parts with 20 annexes.