Search results for " risk-based"
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Evaluating Surface Cleanliness Using a Risk-Based Approach
A risk-based approach, supplemented with laboratory studies and information from published literature, can be leveraged in the justification to reduce testing during cleaning qualification and continu…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Provided is a comprehensive, risk-based transgene characterization strategy; its implementation is based on chemistry, manufacturing, and control (CMC) development phases to ensure that the integrity …
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Eliminating Residual Impurities Starts with a Strategic Plan
A risk-based approach to identifying potential residual impurities is important for understanding any risks to the product quality and potentially the patient. It also allows the development of an opt…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Suitability, or fit for purpose, is assessed either through risk-based commissioning and qualification (e.g., ASTM E2500 [6]), or through the traditional installation, operation, and performance quali…
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Regulatory Challenges in the QbD Paradigm
THE DESIRED STATE FOR REGULATORY AND PHARMACEUTICAL INNOVATION
In 2002, FDA launched Pharmaceutical CGMP for the 21st Century–A Risk-Based Approach , an initiative to encourage the adoption of m…
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Defining Risk Assessment of Aseptic Processes
Management has asked me to do a risk-based assessment so we can use our resources effectively. Can you offer some advice on how I should proceed in putting together this assessment?
A: Aseptic proc…
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Modern Manufacturing Systems Key to FDA Quality Initiative
Woodcock has repeatedly called for industry investment in advanced manufacturing systems as part of her vision for shifting from rule-based to risk-based regulation, offering less oversight of operati…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
“With a lifecycle approach to process validation that employs risk-based decision making throughout that lifecycle, the perception of criticality as a continuum rather than a binary state is more usef…
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A Look Ahead at BioPharma Manufacturing and Regulation
Starting in 2014, inspections will use risk-based methodologies. What factors will the agency use to determine whether and when to inspect a foreign facility?
FDA: We have yet to finalize the r…
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Assessing Manufacturing Process Robustness
The approach supports the organization’s ability to make science- and risk-based continual process improvement decisions for the product as well as to identify areas where QbD development should focus…