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System suitability assessment is an essential part of bioassay methods. The choice of system suitability parameters and their ranges is critical for ensuring the quality of bioassay results…
Viral pathogens can cause wide-spread pandemics (influenza type A, SARS-CoV-2), may have high mortality rates (Ebola virus) and pose enormous health and socioeconomic risks. Certain viruses can also be used as agents for bioterrorism…
A control strategy, according to ICH Q8, is ‘a planned set of controls, derived from current product and process understanding that ensures process performance and product quality…