Design of a Global Sterility Assurance Program

Presented by

Liz Brockson at Takeda and Vanessa Vasadi-Figueroa at Quality Executive Partners

About this talk

Sterility Assurance is an essential component of a contamination control strategy for aseptic processes and manufacturers of sterile products. With the recent revisions to Annex 1 heavily emphasizing the importance of a contamination control strategy for manufacturers, Takeda sought to enhance sterility assurance for aseptic production sites, as well as aseptic practices for low bioburden manufacturing sites. The program was developed via design thinking methodology with quality and manufacturing subject matter experts from global sites coming together in a workshop approach to define current challenges and potential opportunities for the sterility assurance program. The program was designed to be a collaboration between global and local functions to support standardization, harmonization, and implementation of best practices across aseptic manufacturing sites. Ultimately, the program will offer training and capability building on sterility assurance and aseptic practices throughout the network.
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