Search results for " verification"
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Accurately detecting impurities when performing cleaning verification is also difficult because the levels are very low, says Chandrasekaran. “The method must be sufficiently sensitive or cross-contam…
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Understanding Validation and Technical Transfer, Part I
ASTM, E 2500, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment(ASTM International: West Conshohocken, PA, 2007).
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Best Practices for Data Integrity
With an electronic system, you get real-time verification of operator data entry, instead of catching mistakes/missed entry in the final quality control review. Operators receive immediate feedback if…
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Challenges in Analytical Method Development and Validation
This may range from a simple verification, demonstrating that the method still performs as intended, to a full-blown validation for significant changes. In addition, this may impact the regulatory sub…
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Quality by design for biotechnology products—part 1
Part 3 discusses continuous verification and post-approval changes, including topics such as verification at large scale, refinement of the design space, process changes and comparability, comparabili…
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Using Digital Twins to Model Process Chromatography
Into the longer term, we expect to see manufacturing groups further embrace this technology; continued process verification, improved control strategy, and root cause analysis are just three facets th…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
Blockchain is also being evaluated and adopted where appropriate for use in product verification for resale and returns. “It’s not a panacea but another tool in the toolkit,” says Sturtevant.
Curr…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
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What’s New in Upstream Technologies
The device can be stored wet for immediate verification and standardization, eliminating the initial stabilization process. The sensor is packaged with its own calibration fluid, which gives it a two-…
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Automating the Biomanufacturing Process
However, Lebl sees a need for better automated integration of operator training, for real-time verification to ensure that training is up to date. Currently, he says, this is typically done manually. …