Search results for " qualification"

Article Design and Qualification of Single-Use Systems
With increasing regulatory oversight of SUT processes, it’s worthwhile to review basic concepts of design and qualification that apply to single-use components and systems (SUS). Equipment Design …

Article Best Practices in Qualification of Single-Use Systems
66, Application of Single-Use Systems in Pharmaceutical Manufacturing, has been developed to provide comprehensive, high-level guidance about qualification of SUS (1). This paper focuses on technical …

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Stage 2: Criticality and process qualification The FDA Process Validation Guidance requires qualification in that “utilities and equipment are suitable for their intended use” as part of Stage 2 (…

Article Evaluating Surface Cleanliness Using a Risk-Based Approach
The process typically involves performing 100% spray coverage testing, rinse recovery testing, specific or non-specific analytical method qualification, surface sampling and recovery testing of the sa…

Article Understanding Validation and Technical Transfer, Part 2
It is convenient to break down equipment qualification into several steps such as design, installation, and operational as described below for the coffee brewing example. Tasting studies may ha…

Article Going Small to Achieve Success on the Commercial Scale
“There is a lot of documentation and analyses to complete, so in essence, qualification of scale-down models is often an exercise in coordination, rather than presenting a substantial technical challe…

Article Challenges in Analytical Method Development and Validation
…onal antibodies, has lowered the uncertainty/risk for the manufacturer; therefore, less development, qualification, and/or validation work is required. More challenges typically exist for new types o…

Article The Lifecycle Change of Process Validation and Analytical Testing
…trategies and use sound scientific rational to test the effectiveness of those strategies during the qualification of the process; and monitor variability of commercial manufacturing batches to suppo…

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
DQ Design qualification; a documented review of the design, at an appropriate stage of stages in the project, for conformance to operational and regulatory expectations.  drift time The drift time…

Article Being Thorough When Transferring Technology
In technology transfer runs for process performance qualification (PPQ)—a concept that has replaced traditional process validation—each parameter should have a criticality classification with a justif…

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