Therapeutic Goods Administration(TGA) of Australia 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 . 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.
This notice is being issued to assist with the transition period. It is a point-in-time document and TGA is not planning on updating this notice. TGA will be updating GMP guidance during 2020 to reflect the new requirements. The notice contains a summary table of new and amended GMP requirements and a transition period from 1 July 2020 to 1 July 2021 to allow manufacturers to assess and plan for these changes and permit time for implementation.
TGA’s expectation is that by 1 January 2021, manufacturers will have:
• completed their assessment of the impact of the new manufacturing principles on their operations; and
• completed, or be well advanced, towards updating quality systems documentation and implementing revised practices
Further information pertaining to the guideline could be referred to https://www.tga.gov.au/resource/transition-new-gmp-requirements-medicinal-products