Search results for " quality"

Article The Metrics of Quality Culture
Schniepp The long awaited, anxiously anticipated FDA guidance on quality metrics was finally distributed for comment on July 28, 2015. The official title of this guidance for industry is Request f…

Article Quality by design for biotechnology products—part 1
…erence on Harmonization (ICH) Q8(R2), Q9, and Q10 guidelines provide the foundation for implementing Quality by Design (QbD). Applying those concepts to the manufacture of biotech products, however, …

Article State of Quality and Compliance in the Biopharmaceutical Industry
The following years witnessed FDA's launching of multiple initiatives in an attempt to inspire the industry to achieve higher standards of quality and compliance. Among these initiatives are the Pharm…

Article Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (I…

Article A Look into the Future of Biopharmaceutical Quality
These complex therapies have evolved, and with this evolution comes new challenges in ensuring the quality of these products and the safety of the patients that use them. Quality regulations, and indu…

Article Quality by design for biotechnology products—part 3
…erence on Harmonization (ICH) Q8(R2), Q9, and Q10 guidelines provide the foundation for implementing Quality by Design (QbD). Applying those concepts to the manufacture of biotech products, however, …

Article Modern Manufacturing Systems Key to FDA Quality Initiative
At the same time, more transparent company reports on quality operations, market pressures to cut costs, and public demands for reliable patient access to critical therapies are combining to support a…

Article Quality by design for biotechnology products—part 2
…erence on Harmonization (ICH) Q8(R2), Q9, and Q10 guidelines provide the foundation for implementing Quality by Design (QbD). Applying those concepts to the manufacture of biotech products, however, …

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
  In Part I, the author used risk analysis and applied the continuum of criticality to quality attributes during the process design stage of process validation. After using process kno…

Article Quality by Design and Extractable and Leachable Testing
While these materials may meet the functional goals of the container closure, if quality is considered at the beginning of the process, harmful contaminants may inadvertently be introduced into the dr…

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