Search results for "FDA"
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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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Vaccine Development and Production Challenges Manufacturers
Researchers are advancing new vaccines for Ebola and other devastating diseases, while manufacturers work with FDA to bring to market new products to combat dangerous infections and strategies to impr…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
Specifically, FDA outlines in the aforementioned guidance that protein aggregates elicit an immune response in humans through the following mechanisms: by causing B-cell activation as a result of cros…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
With the most recent FDA (1) and Inter-national Conference on Har-monization (ICH) guidances (2-4) advocating a new paradigm of process validation based on process understanding and control of paramet…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
At the same time, regulatory scientists at agencies such as FDA have very sophisticated analytical capabilities and well-trained staff. Increased communication between biopharma manufacturers, their s…
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Avoiding Investigational Failures and Discrepancies
By Walt Murray, James Jardine
Investigations-focused regulatory standards that apply to life-sciences organizations, such as FDA 21Code of Federal Regulations (CFR) 211.192, mand…
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Best Practices in Qualification of Single-Use Systems
Regulatory Requirements
For finished pharmaceuticals, FDA has issued regulations explaining cGMPs in 21 Code of Federal Regulations (CFR) 210 and 211 (5, 6). For APIs or drug substances, however, …
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Moving Biosimilars Forward in a Hesitant Market
“Even though FDA has things in place, and there have been many talks that there is much money spent on a clinical trial to show that [a biosimilar and its innovator product are interchangeable], much …
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Successfully Moving Regulated Data to the Cloud
Changing working practices and regulations
One example from FDA’s guidance document describes the use of shared login accounts. Previously, shared accounts have been used to conveniently access a r…
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Process Development: What May Lie Ahead in 2018?
While only 22 new drugs were approved in 2016, FDA gave its thumbs up to 46 new drugs in 2017 (of which approximately one-quarter were biologics). The figures for all new drug approvals are in line wi…