Search results for " quality"
Article
Quality Systems Key to Lifecycle Drug Management
There’s renewed support for developing an international quality standard for regulating postapproval changes. And new policies and procedures at FDA aim to streamline oversight of manufacturing change…
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Quality by Design—Bridging the Gap between Concept and Implementation
…nes of the International Conference on Harmonization (ICH) covering pharmaceutical development (Q8), quality risk management (Q9), pharmaceutical quality systems (Q10), and the development and manufa…
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Drug Quality Key to Innovation and Access
Manufacturing challenges
Accelerated FDA approval of important therapies demands drug manufacturing systems able to scale up production quickly and efficiently and to maintain quality throughout th…
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Essentials in Quality Risk Management
Quality risk management (QRM), as defined in International Conference on Harmonization's (ICH) Q9 document (1), is designed to ensure that drug critical quality attributes (CQAs) are defined and maint…
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Reporting Quality Metrics to FDA
Since the publication of FDA’s draft guidance, Request for Quality Metrics, Guidance for Industry (1), in July 2015, we have been debating how to best capture and report quality metrics in our organiz…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
A critical quality attribute (CQA) has been defined as “a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distributi…
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Using Quality by Design to Develop Robust Chromatographic Methods
48-64
The quality-by-design principles that enable a manufacturer to limit and control the sources of process variability are equally important to measurement systems, because the variability in …
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Application of Quality by Design to Viral Safety
40-47
The biotech industry has begun to implement a quality-by-design (QbD) approach to ensure the quality of biopharmaceuticals. Using this approach, products are developed with a thorough under…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Complexity—in particular, determining which product attributes are most crucial to product quality and patient safety—makes it challenging to apply quality-by-design (QbD) methods and process analytic…
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Critical Quality Attributes Challenge Biologics Development
By Susan Haigney
Critical quality attributes (CQAs) are used in biopharmaceutical development to gain an understanding of a product and the processes used to make that product. The International C…