Australia – Transition to new GMP requirements for medicinal products

A notice about the implications of adopting the PIC/S Guide to GMP PE009-14

The TGA will adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-14 (PIC/S Guide to GMP), excluding Annexes 4, 5 and 14, as the manufacturing principles for medicines and active pharmaceutical ingredients, with effect from 1 July 2020 as communicated on 4 May 2020. The PIC/S Guide to GMP is available from the PIC/S website.

This will replace the manufacturing principles adopted in 2018 by the TGA for the manufacture of medicines, active pharmaceutical ingredients and sunscreens: the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-13…