Good manufacturing practice (GMP) requirements for medicinal products: PIC/S Guide to GMP PE009-17

Purpose

This guidance is for Australian sponsors and manufacturers of medicines, active pharmaceutical ingredients (APIs) and sunscreens made or supplied in Australia.

It provides a summary of the changes in good manufacturing practice (GMP) requirements resulting from the recent replacement of the PIC/S Guide to GMP for Medicinal Products (PE 009-16, 1 February 2022) with PE 009-17, 25 August 2023.

The most significant change resulting from the adoption of the more recent version of the PIC/S Guide related to updates to Annex 1 for the manufacture of sterile medicinal products.

There are no other changes to the guidance, therefore manufactures of non-sterile medicines, non-sterile active pharmaceutical ingredients (APIs) and sunscreens are not materially affected by this update.

Changes to the PIC/S Guide to GMP 

From 1 September 2025 the PIC/S Guide to GMP version 17 applies to the manufacture of medicines, APIs and sunscreens, unless exempt under provisions in the Therapeutic Goods Act 1989 (the Act). 

There is a 6-month transition period for adoption of some changes to Annex 1 to allow manufacturers to review and make necessary operational changes. The guidance below provides details of these changes and expected actions and timeframes for compliance.