Good manufacturing practice (GMP) requirements for medicinal products: PIC/S Guide to GMP PE009-16

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 009-15, 1 May 2021) with PE 009-16, 1 February 2022. 

The most significant change resulting from the adoption of the more recent version of the PIC/S Guide is inclusion of the new Annex 16.

Changes to the PIC/S Guide to GMP 

From 3 June 2024 the PIC/S Guide to GMP version 16 applies to the manufacture of medicines, APIs and sunscreens, unless exempt under provisions in the Therapeutic Goods Act 1989 (the Act). 

There is a 3-month transition period for adoption of the new Annex 16 to allow manufacturers to review and make necessary operational changes. All other changes are minor (i.e., clarifications in Annex 13) and are in force from 3 June 2024.