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Transition to new GMP requirements for medicinal products
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.
This notice is being issued to assist with the transition period. It is a point-in-time document and we are not planning on updating this notice.
We will be updating GMP guidance during 2020 to reflect the new requirements.
- A notice about adoption of a new PIC/S guide to GMP
- New and amended GMP requirements
- Transition plan
|Version||Description of change||Author||Effective date|
|V1.0||Original publication||Manufacturing Quality Branch||June 2020|
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