Glossary Terms (Simple List)
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Validation, partial
A documented prospective study intended to demonstrate suitability for the intended use of previously validated methods, specifically for new products and/or processes. (TR57)
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Value Stream Map
A tool used to document, analyze, understand and improve the flow of information or materials required to produce a product or service for a customer as it makes its way through the value stream. (TR68)
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Value-added Activities
Includes the management of materials, operations, qualification, verification, vender audits, materials testing, and shop-floor oversight that allows an SUS to be used in operations. (TR66)
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Vapor
The gaseous form of materials that are normally liquids or solids at room temperature and pressure. (TR51)
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Vapor Phase Hydrogen Peroxide (VPHP)
A disinfection system in which 35% hydrogen peroxide is changed to a vapor phase and used for bioburden reduction of a chamber or items in a chamber. (TR70)
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Vegetative Cell
Cells in an actively growing state. Some microorganisms can only be vegetative, while others are sporeformers and can be in a vegetative or spore (dormant) state. (TR13)
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Velocity
The average linear rate of fluid flow equal to the volumetric flow rate divided by the cross-sectional area of the flow channel. (TR15)
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Verification
A systematic approach to verify that manufacturing systems, acting singly or in combination, are fit for intended use, have been properly installed, and are operating correctly. This is an umbrella term that encompasses all types of approaches to assuring equipment is fit for use. Approaches include qualification, commissioning and qualification, verification, system validation, or other. (TR3) (TR60)
A systematic approach to verify that manufacturing systems, acting alone or in combination, are fit for intended use, have been properly installed, and are operating correctly. This is an umbrella term that encompasses types of approaches such as qualification, commissioning and qualification, verification, and system validation. (TR60-2)
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Verification Accredited Wholesale Distributors (VAWD)
An accreditation governed by the U.S. National Association of Boards of Pharmacy for pharmaceutical wholesale distribution facilities indicating that they are in compliance with state and federal laws. (TR52)
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Verified Clean
The verified clean testing materials undergo a cleaning or washing process to remove particulates with an evaluation for acceptance (e.g., blank) to assure the system’s suitability for use in testing or inspection. (TR79)