Please define the meaning of “risk” from the perspective of environmental monitoring. Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with ...

The authors question certain aspects of the industry's current regulatory-compliance strategy and suggest that aseptic-process control and evaluation should be revised. Numerous points of special ...

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 ...

Limited remote, continuous measurement and poor instrument/software interconnectivity impede manufacturing management (enterprise) system deployment and restrict the use of analytical results for real ...

Why is aseptic processing important in pharmaceutical manufacturing? The manufacturing of both sterile drugs and biological products can be achieved through terminal sterilization or aseptic ...