Isabella Jul-Jørgensen (Technical University of Denmark and Novo Nordisk)

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Leveraging PAT for environmental monitoring in light of Annex 1

8 September 2023 | By Isabella Jul-Jørgensen (Technical University of Denmark and Novo Nordisk)

The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from the Technical…

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An Annex 1 and Pharma 4.0 perspective on water quality

20 October 2022 | By Isabella Jul-Jørgensen (Technical University of Denmark and Novo Nordisk)

Pharma 4.0 is coming and is further driven by the recent update of the EU GMP Annex 1 regarding manufacturing of sterile medical products, setting new regulatory expectations in all manufacturing processes. Here, Isabella Jul-Jørgensen from the University of Denmark focuses on sterile water quality and how the new requirements…