Search results for " system" in Articles / App Notes
Article
Global Expansion Shapes Drug Oversight
…ion of US substances registration software in the EU, with an eye to forming a global identification system for medicinal products.
And last month, Howard Sklamberg, deputy commissioner for Gl…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Techniques of measurement system analysis such as Gage repeatability and reproducibility (Gage R&R) studies are recommended because they provide information on the variability of the measurement syste…
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Essentials in Establishing and Using Design Space
Why Establish a Design Space?
There are three steps in the development of any product or process: system design, parameter design, and tolerance design. System design is the definition of the sy…
Article
Flexibility in Biopharmaceutical Manufacturing
By this route, the flexible biomanufacturing system will perhaps deliver transformative change that many in the industry are hoping to witness.
Simon Chalk is director of the BioPhorum Operatio…
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Advancing QbD in the EU
These guidelines cover pharmaceutical development concepts in Q8, quality risk management (QRM) in Q9, and a pharmaceutical quality system to be implemented in the different stages of a product lifecy…
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The Lifecycle Change of Process Validation and Analytical Testing
In-line, continuous monitoring, and control systems, such as those associated with PAT, are helpful in maintaining and assuring process control. Assurance of process control can be obtained by observa…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Digital technology was adopted to track novel endpoints, and the value of utilizing real-world data and real-world evidence from healthcare systems and disease registries gained acceptance for support…
Article
Assessing Manufacturing Process Robustness
ICH guidelines Q8–Q12 (1–5) and those in development such as ICH Q14 (6) have applied science, risk management, and quality systems to enhance process and product quality.
In 2011, …
Article
Genetic Vaccine Platforms Demonstrate Their Potential
“This issue can make repeated dosing difficult, since with additional dosing, the patient’s immune system may clear the viral vector before it has an opportunity to insert the nucleic acid into a cell…
Article
Visualize your ÄKTA Pilot 600S in 3D
When when thinking of getting a new system, add components and study 3D models of systems like ÄKTA pilot 600S, ÄKTA avant, ÄKTA pure, ÄKTA go, and ÄKTA start in Cytiva’s Puri…