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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 May 2021, PE009-15, except for its Annexes 4, 5, and 14. This version of the PIC/S Guide was adopted on 1 July 2022.
This notification is to advise we are moving to a more recent version and will be adopting the PIC/S Guide to GMP – 1 February 2022, PE009-16, except for Annexes 4, 5 and 14 on 3 June 2024.
What are the main changes?
The changes in version 16 relate to Annex 13 and Annex 16.
Annex 13 – This annex has been amended and contains information and requirements to address specific issues related to the manufacture of investigational medicinal products.
Annex 16 – Australia is now adopting Annex 16 which provides information and requirements on the certification by an authorised person and on batch release of medicinal products.
How will the new Guide to GMP be adopted?
The adoption of the PIC/S Guide to GMP – 1 February 2022, PE009-16 is planned to commence on 3 June 2024 from which point GMP inspectors will use the new Guide to GMP during inspections. Compliance with the requirements of the PIC/S Guide to GMP – 1 February 2022, PE009-16 will be expected from the date of adoption.
We have held several industry consultations over the past year and will continue to work with industry to develop further interpretative guidance where required.
We will publish further guidance on the adoption and interpretation on the PIC/S Guide to GMP – 1 February 2022, PE009-16.
What actions do manufacturers need to take now?
Manufacturers are encouraged to review the PIC/S Guide to GMP – 1 February 2022, PE009-16 and ensure you are familiar with the requirements relevant to your manufacturing operations.