Glossary Terms (Simple List)
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Decommissioning
A planned and orderly removal of a facility, operation or system from use. (TR48)
The process of retiring equipment/systems/facilities from production use. (TR54-5)
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Decontamination
A process that is designed to remove soil (including microorganisms) and may consist of cleaning and/or disinfection. (TR51)
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Dedicated Equipment
Equipment used exclusively for the manufacture of only one drug product, bulk drug substance, or intermediate. (TR29)
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Defect
(1) A departure of a quality characteristic from its intended level or state that occurs with a severity sufficient to cause an associated product or service not to satisfy its intended normal or foreseeable usage requirements. (TR51)
(2) The nonfulfillment of intended usage requirements. The departure or absence of one or more quality characteristics from intended usage requirements. (TR43)
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Defect (ANSI def.)
A departure of a quality characteristic from its intended level or state that occurs with a severity sufficient to cause an associated product or service not to satisfy its intended normal or foreseeable usage requirements. (TR76)
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Defect (ISO def.)
The nonfulfillment of intended usage requirements. The departure or absence of one or more quality characteristics from intended usage requirements. (TR76)
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Degradation
The breakdown (usually chemical) of material during manufacture, including during and after the cleaning process. (TR49) (TR70)
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Degradation Product
Molecular variants resulting from changes in the desired product or product-related substance brought about over time and/or by the action of light, temperature, pH, water, etc., or by reaction with an excipient and/or the immediate container/ closure system. Such changes may occur because of manufacture and/or storage (e.g., deamidation, oxidation, aggregation, proteolysis). Degradation products may be either product-related substance or product-related impurities. (TR57)
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Deionized Water
Water treated by passing through both cation- and anion-exchange resin beds, or a mixed-resin bed to remove both positive and negative ions. (TR45)
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Deployment
Activities involving the hands-on steps required to successfully assemble and make a system ready for use for a specific SUS application. (TR66)