Search results for " risk-based"
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Modular Manufacturing Platforms for Biologics
The level of segregation between processing areas should be determined using a risk-based approach and should consider air handling, viral processing, live organism zones, and cell cultivation and cel…
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Continuous Manufacturing: A Changing Processing Paradigm
FDA support for quality improvements
FDA has been a strong supporter of continuous processing as early as 2004 when it released Pharmaceutical cGMPs for the 21st Century–A Risk-Based Approach. In …
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New Era for Generic Drugs
The risk-based review approach has already paid off with a 50% reduction in chemistry review times this past year, she noted.
A main strategy for speeding up ANDA review and approval is to reduce t…
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Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…
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Evaluating Design Margin, Edge of Failure and Process
Using a risk-based and multivariate approach is a best practice in generating the design space. Determination of failure rates and design margin during development is a best practice. One should inclu…
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Quality by Design—Bridging the Gap between Concept and Implementation
There would also have to be “enhanced scientific and risk-based approaches to QbD to match new technologies with a simplified and streamlined variations process,” said Tainsh and Pugh.
There have b…
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Implementing QbD in Sterile Manufacturing
Consequently, risk mitigation activities can be developed, and a risk-based control strategy implemented from the very beginning of the commercial stage, forming the basis for improvement of quality a…
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Supplier-Change Management for Drug-Product Manufacturers
This process is typically risk-based, and defines the evaluations and outcomes that need to be managed, as well as the specific deliverables required to establish that the change has been implemented.…
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FDA Seeks Metrics to Define Drug Quality
An upgraded IT platform could compile information from all sources on sites and products to support a streamlined, risk-based inspection process. This initiative also could evaluate FDA performance, s…
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Essentials in Establishing and Using Design Space
Using a risk-based and multivariate approach is a best practice in generating the design space. Use of design space is best when establishing set points, tolerances, and PAR ranges. Best practices inc…