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The Impact of Annex 16 Adoption by PIC/S in Australia

August 07, 2023

The Therapeutic Goods Administration (TGA) is part of the Australian Federal Government’s Department of Health and regulates the supply, import, export, manufacturing, and advertising of therapeutic goods, including medicines in Australia.

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Authorised Person Responsibilities in Pharma / MD Release for Supply

March 29, 2016

When handling a pharmaceutical or medical device, it is imperative in the eyes of the regulator, such as the TGA or FDA, that people within your organisation are assigned appropriate roles and responsibilities. One of the most important roles is that of the Authorised Person, who is responsible for authorising steps of the manufacturing process,...

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