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Regulatory Panel: Annex 1 Implementation |
The updated Annex 1 has been released end of August, introducing changes which require more stringent sterile manufacturing processes, including implementing a contamination control strategy and new technology to reduce the risk of contamination. In this panel, Regulators will discuss those changes and how they impact our manufacturing practices and consider how Pharma 4.0ÿ concepts such as data management and clean room monitoring can assist with Annex 1 implementation. More work is now needed to bring clarification which could be needed in the future for a better implementation of this new document, training for all stakeholders and regulators will be needed to have an harmonized application of the new Annex 1.