Search results for "validation"
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Additional benefits will be providing a way to upskill the workforce and to focus on regulatory concerns, such as model validation and change management. Results and the white paper are due to be rele…
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New Column for Scale-Down Studies
Discover Validation Columns
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Nurturing Knowledge from Disparate Data Streams
“A method for plant operators to use for determining that a lot spectrum conforms to a standard should be rugged and allow for simple acquisition and validation. Ultraviolet (UV) analysis is one examp…
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Applying GMPs in Stages of Development
Areas to be reviewed to determine the appropriate level of control needed in concert with the phase development stage include: level of validation of test methods, level of detail needed in batch reco…
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Navigating Data Integrity in the Modern Lab
While validation is still necessary, this removes both the day-to-day complexity in the lab and much of the risk of compromised data integrity.
PharmTech: How can manipulation of electron…
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Industry Adoption of Single-Use Systems Remains Low
In addition, equipment validation is required before re-use (4).
To put the time consideration into perspective, a typical clean-in-place cycle for vessels between 100 L to 1000 L can run…
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Bioburden Control in the Biopharmaceutical Industry
Clontz, Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements, (CRC press Taylor & Francis, Boca Raton, FL, 2nd ed., 2009).
2. A.M. Cundell, “Comparison of Microbiol…
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Mechanistic Modeling of Preparative Ion-Exchange Chromatography
Development of a mechanistic model requires three major steps: modeling of mass transfer, modeling of binding, and finally, validation of the mechanistic model. The choice of details depends on the de…
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Single-use Bioreactors Have Reached the Big Time
Film validation using harmonized methods will, in the future, establish a framework for comparison and validation of product contact films for a process, reducing time and effort for the user, notes O…
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Technical and Process Economical Aspects of Using Capto™ Q and ReadyToProcess™Adsorber Q in mAb Polishing
…cleaning and storage, as well as process time, for example, by minimizing the need for cleaning and validation operations and by allowing for higher flow rates.
While sometimes perceived as costl…