Search results for " Lifecycle"
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The Lifecycle Change of Process Validation and Analytical Testing
Typically, this included a smaller number of discrete pieces of data, significantly less than that generated by continuous process monitoring as part of the lifecycle approach.
The identifi…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The FDA guidance points to a lifecycle approach to process validation. (see Figure 1).
In Part I, the author used risk analysis and applied the continuum of criticality to …
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Quality Systems Key to Lifecycle Drug Management
CDER’s new Office of Pharmaceutical Quality (OPQ) seeks to tackle these problems through more seamless integration of review, inspection, and surveillance throughout the product lifecycle, commented O…
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Assessing Manufacturing Process Robustness
In 2011, FDA’s revised process validation (PV) guidance (7) extended ICH’s concepts to the pharmaceutical product lifecycle, an approach that is now being applied to cleaning validation and other area…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
Since then, the lifecycle model has become the “gold standard” for all types of processes including cleaning validation; it provides a better understanding of the design and monitoring of the cleaning…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
The FDA guidance points to a lifecycle approach to process validation (see Figure 1). “With a lifecycle approach to process validation that employs risk-based decision making throughout that lifecycle…
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Efforts Accelerate to Streamline Postapproval Change Process
Expanded global sourcing and sales complicates lifecycle product management, though, by requiring sponsors to deal with dozens of regulatory authorities that follow widely varying rules and legal requ…
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Leveraging Data for Better Biopharmaceutical Process Control
One major challenge is developing a lifecycle approach to using PAT and advanced control that would allow these approaches to be used, from R&D through biopharmaceutical tech transfer, and manufacturi…
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Continued Process Verification for Biopharma Manufacturing
Guidance issued by FDA in 2011 (1) emphasized the importance of manufacturers undertaking CPV as an integral part of the process validation lifecycle. CPV will provide the manufacturer with assurance …
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Using Quality by Design to Develop Robust Chromatographic Methods
It is important to note that it is not a one-time process but instead is an iterative one that should be revisited throughout the lifecycle of a method. Risk assessments or experiments performed again…