May 5, 2020

Manufacturing Quality Branch (MQB), Therapeutic Goods Administration (TGA), Australia has notified that they are intending to adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-14) issued, 1 July 2018, as the manufacturing principles for medicines, active pharmaceutical ingredients and sunscreens.

The TGA’s Manufacturing Quality Branch (MQB) is responsible for the assessment, inspection and licensing/certification of manufacturers of medicines supplied to, or exported from Australia.

The current manufacturing principles adopted by the TGA for the manufacture of medicines, active pharmaceutical ingredients and sunscreens is the PIC/S Guide to Good Manufacturing Practice, (PE009-13) issued 1 January 2017 (excluding Annexes 4, 5 and 14). This guide was adopted by the TGA in 2018.

TGA has scheduled the implementation from 1 July 2020 and expects the manufacturing firm to comply with the PIC/S Guide to GMP (PE009-14, 1 July 2018), after which, GMP inspectors will use the new Guide to GMP during inspections. TGA has also ensured that the GMP inspectors will take a pragmatic approach to discussing and reporting deficiencies relating to any new supplementary requirements.

A 12 month graduated transition period will be provided to allow manufacturers time to assess the new supplementary requirements and implement changes to procedures and practices to fully comply with the new guide. Full compliance with the PIC/S Guide to GMP (PE009-14, 1 July 2018) will generally be expected after this 12 month transition period ends.

Acknowledging the impact of COVID-19 pandemic on the ability of manufacturers to adopt new supplementary requirements, TGA planned to review the overall implementation period prior to the completion of the 12 month graduated transition period, to determine whether additional time is required.

 

Source: https://www.tga.gov.au/update-manufacturing-principles-medicines-apis-sunscreens