The TGA has published details of the 12 month graduated transition period to PIC/S Guide to GMP PE 009-13, commencing 01 January 2018. The key changes and a transition plan have been summarised in tables by chapter and appendix and are linked here for your convenience.
The TGA announced on 13 September 2017 that it will adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-13) as the Manufacturing Principles for medicines, active pharmaceutical ingredients and sunscreens from 31 December 2017.
Copyright © SeerPharma
