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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