Search results for " Lifecycle"
Article
Using Software in Process Validation
Pharmaceutical software systems for process validation
Validation software systems help manage and keep track of all types of activities that take place over the lifecycle of the product and proce…
Article
Addressing the Complex Nature of Downstream Processing with QbD
…ents (DoE), use of quality risk management, and use of knowledge management throughout a product’s lifecycle (1). QbD incorporates the identification of critical quality attributes (CQAs) through a q…
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Supply Chain Challenges for Single-Use Systems
Cytiva published a peer-reviewed single-use system lifecycle analysis (4). The results of this analysis showed that single-use consumables provide a better choice from the environmental impact perspec…
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Understanding Validation and Technical Transfer, Part I
Why validate?
Validation is necessary throughout a product’s lifecycle, from initial development through commercialization, to ensure it is safe and effective. The molecule originally identified a…
Article
Applying GMPs in Stages of Development
…uct quality and patient safety regardless of the stage of development a product is at in the product lifecycle.
The criticality of an efficient change-control system that can track and ensu…
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Managing Residual Impurities During Downstream Processing
“They are intended,” he adds, “to support and complement regulatory assessment and could be applied throughout the product lifecycle.” USP sets public quality standards and FDA enforces such standards…
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Advancing Single-Use Technology Through Collaboration
A comprehensive study used lifecycle assessment to examine the environmental impacts of single-use technology across the full process train. This study found that single-use technology resulted in les…
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Innovation vs. Capacity: How CMOs Compete
Capacity-driven CMOs are focused on filling largely undifferentiated manufacturing capacity primarily by producing generics, undifferentiated over-the-counter (OTC) medications, and late lifecycle bra…
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Breakthrough Drugs Raise Development and Production Challenges
The initiative, he noted, requires risk-based assessment strategies and a product quality lifecycle management plan, combined with clear analysis of what can be evaluated during review, and what can b…
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Discovering the unknown: How does in silico process development change PD scientists’ work?
What are some typical use cases?
Nora Ketterer: Once a model is calibrated, it can be used to support the entire PD lifecycle. Recently, we worked with scientists at Takeda. There, we used m…