The current COVID-19 pandemic and the measures put in place to control it is having a big impact from both a personal and a business perspective. We, as an industry, need to adapt to the current way of working and push through to ensure our processes are in control, projects are completed, and we stay…
The TGA recently held a webinar to discuss the recent reforms to medicinal cannabis legislation and it included: GMP requirements for imported products to level the playing field for local manufacturers Updated labelling and packaging details in TGO 93. Updates to medicinal cannabis compounding permissions. I have discussed how to ensure GMP compliance for imported…
This is the second of a two-part blog covering the changes to PIC/S version 16. Previously we discussed changes to Annex 13 – Manufacture of Investigative Medicinal Products, and today I am doing a comparison of the new Annex 16 – Certification by the Authorised Person and Batch Release and comparing it against the TGA’s…
Historically, the PIC/S GMP Guide has chapters and annexes revised, aligned and corrected to close the gap between the international GMP guidelines and to further develop and harmonise GMP standards. PIC/S PE 009-16 (or version 16) of the Guide, recently entered into force on the 1st February 2022, and includes changes to Annex 13 “Manufacture…
During a webinar last year, the TGA announced they were intending to introduce changes to the medicinal cannabis regulations (including supplier assurance requirements for imported medicinal cannabis products). In light of that, a TGA consultation on potential reforms to medicinal cannabis manufacturing, labelling and packaging has just closed. As a result, there are three key…
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