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.
Notice: https://www.tga.gov.au/transition-new-gmp-requirements-medicinal-products
New and amended requirements: https://www.tga.gov.au/book-page/new-and-amended-gmp-requirements
Transition plan: https://www.tga.gov.au/book-page/transition-plan
While the changes have been neatly summarised, the workload is significant, requires a range of expertise and should not be underestimated. For instance, the new code will require you to prepare a Quality Manual and Site Master File. This could potentially mean unnecessary duplication and management effort to keep them aligned. We can assist by integrating both in to one document that can easily be maintained.
Contact us to fast-track your implementation of PIC/S GMP Guide (PE 009-13).
