Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing. A. Aseptic processing is a manufacturing method that can ...

Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, guided by regulatory frameworks like FDA and ICH. Technological advances, ...

This article outlines improvements and changes to non‐viable particle monitoring (NVP), sometimes referred to as total particulate monitoring, which during aseptic processing, is a regulatory ...

Today’s market demand on biologic and pharmaceutical manufacturers to develop new drugs - combined with the economic environment - is challenging bio-processors to review their processing systems and ...

To assure patient safety, biologics developers and manufacturers must carefully consider where contaminants could be introduced to the drug substances (DSs) or drug products (DPs) at all stages of the ...

Dublin, July 28, 2025 (GLOBE NEWSWIRE) -- The "New EU (European Union) GMP (Good Manufacturing Practice) Annex 1: Compliant Aseptic Operations Training Course" has been added to ResearchAndMarkets.com ...