Quick Takes From Takeda Austria's Annex 1 Rollout
Maria Löflund, site head at Takeda Manufacturing Austria AG, has provided insights into the implementation of the latest Annex 1 update during the 2024 ISPE Aseptic Conference in Vienna, Austria. The update is aimed at modernizing aseptic pharmaceutical manufacturing practices.
Löflund highlighted key aspects such as the mandatory contamination control strategy, pre-use-post-sterilization integrity testing, and addressing the human factor in aseptic operations. She emphasized the importance of integrating aseptic practices into facility design for new sites and outlined strategies for legacy sites to minimize disruptions to the supply chain during implementation. Additionally, Löflund stressed the need for early involvement of corporate management in developing long-term investment plans to modernize aseptic processing lines. Löflund's insights offer valuable guidance for navigating Annex 1 compliance in the pharmaceutical manufacturing sector.
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