Search results for " risk assessment"
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Risk Assessment Challenges in Biopharma
BioPharm: What top challenges do companies face when performing risk assessment in biopharmaceutical manufacturing compared with solid-dosage manufacturing?…
Article
Assessing Manufacturing Process Robustness
Criticality assignment (Step 2)
Upon identifying the risk factors through cause-and-effect techniques, a risk-rating decision tree (Figure 3) is used to analyze the process upon risk asse…
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Defining Risk Assessment of Aseptic Processes
High-risk areas to assess
One of the most critical areas for establishing your risk assessment is the subject of proper gowning technique. If the operator can’t follow the proper gowning requiremen…
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Assessing leachables risk over a complete single-use, mAb process
Single-use systems (SUS) in biopharmaceutical manufacturing give advantages such as improved flexibility and plant efficiency, but also raise concern for compounds leaching from the pol…
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Risk Assessment: Studying Chromatography Resin Variability
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Many factors can give rise to process variability, such as variation in different process parameters or raw materials. This article focuses on process robu…
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Essentials in Quality Risk Management
First, risk assessment should be based on scientific knowledge associated with product and process understanding, and second, the level of effort associated with risk assessment/management should be c…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
An initial risk assessment was then completed to determine a preliminary continuum of criticality for process parameters.
In Part II, the preliminary risk levels of process parameters…
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Regulatory Challenges in the QbD Paradigm
Regulators also must offer more flexibility regarding manufacturing changes and application supplements based on science and risk assessment, so that limited resources on both the industry and regulat…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
• Introduce a risk assessment for animal- and human-origin components.
• Develop a policy of “three Rs” (replacement/reduction/refinement) for animal- and human-origin components.
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Article
Evaluating E&L Studies for Single-Use Systems
Extractables and leachables evaluation
An extractables and leachables evaluation should begin with a risk assessment of the materials to determine whether there is a significant risk that may requ…