EU GMP Annex 1 has pushed sterile manufacturing conversations from “what does it mean?” to “how is it proven?” Annex 1 requires a facility-wide, integrated contamination control strategy (CCS) that defines critical control points, verifies the effectiveness of design and operational controls, and is actively reviewed to drive continual improvement.
The pharmaceutical industry continues to face increasing demands for more efficient and effective manufacturing processes, particularly when it comes to aseptic processing. With an emphasis on safety, sterility, and the quality of biologics and injectables, the field of aseptic processing is critical for delivering life-saving medications. ISPE invites all pharmaceutical professionals to join...
In the intricate world of pharmaceuticals, where precision and safety are paramount, the marriage of innovation and sustainability is not just an aspiration—it's a necessity. Picture a scenario where the pursuit of product purity meets the responsibility to our planet. Welcome to the realm of "Eco-friendly Pharma: Sterilization and Sustainable Practices." As we embark on this exploration,...
