Search results for "process verification"
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Stage 3: Criticality and continued process verification
At the conclusion of a successful PPQ, process validation activities move into an ongoing monitoring and review phase called continued proce…
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The Lifecycle Change of Process Validation and Analytical Testing
Jones (Innopharma Labs): A manufacturer can only truly understand their process and successfully demonstrate continued process verification through the implementation of process analytical testing (PA…
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Assessing Manufacturing Process Robustness
The assessment focuses on analyzing the information and knowledge gained from the three stages of the process validation lifecycle: process design, process performance qualification, and continued pro…
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Continued Process Verification for Biopharma Manufacturing
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Continued process verification (CPV) is the activity that provides ongoing verification of the performance of a manufacturing process. Guidance issued by FDA in 2011 (1) emphasized the impo…
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Reducing Cross-Contamination Risks in Process Chromatography
Reducing Cross-Contamination Risks in Process Chromatography
Single-use systems provide replaceable fluid paths.
By Cynthia A. Challener
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Using Digital Twins to Model Process Chromatography
Into the longer term, we expect to see manufacturing groups further embrace this technology; continued process verification, improved control strategy, and root cause analysis are just three facets th…
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Automating the Biomanufacturing Process
As automation in biomanufacturing becomes more important, so does the need to integrate process data.
By Feliza Mirasol
unlimit3d/Stock.Adobe.com
Biomanufacturing proc…
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Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
By Cynthia A. Challener
Manufacture of protein and other biologic drug substances via …
Article
Single-use technologies in downstream process intensification
In bioprocessing, thorough cleaning is critical in order to take full benefit of the resin by removing impurities. When using conventional chromatography solutions, cleaning and cleaning validation …
Article
Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…