Transition to new GMP requirements for medicinal products

This document is for Australian sponsors and manufacturers of sterile medicines and active pharmaceutical ingredients (APIs) made or supplied in Australia. It provides a summary of the changes in GMP requirements resulting from the recent replacement of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE 009-16, 1 February 2022, with PE 009-17, 25 August 2023.

Contents

• Purpose
• New and amended GMP requirements
• Summary of new and amended requirements
• Transition plan