Glossary Terms (Simple List)
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Depth Filter
A matrix of randomly distributed fibers creating a tortuous path with pores of undefined size and shape. A filter that removes particles by a combination of adsorption and size exclusion within its porous matrix rather than on its frontal surface. (TR45)
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Depyrogenation
The destruction and/or removal of bacterial endotoxins. A depyrogenation process should demonstrate at least 99.9% or a 3-log endotoxin reduction. (TR3)
Removal or destruction of pyrogens. (TR70)
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Design of Experiments (DOE)
A method for carrying out carefully planned experiments on a process. Usually, DoE involves a series of experiments that initially involves evaluating many variables and then focuses on a few critical ones. (TR54-4)
A structured, organized method for determining the relationship between factors affecting an assay and output of that assay. (TR57) (TR57-2) (TR74)
A structured, organized method for determining the relationship between factors affecting a process and the output of that process (8). (TR60)
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Design Qualification (DQ)
Documented verification that the proposed design of the systems is suitable for the intended purpose. Also establishing confidence that ancillary component systems are capable of consistently operating within established limits and tolerances. (TR39) (TR48) (TR64) (TR 72)
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Design Reviews
Planned and systematic reviews of specifications, design, and design development and continuous improvement changes performed as appropriate throughout the lifecycle of the manufacturing system. Design reviews evaluate deliverables against standards and requirements, identify problems, and propose required corrective actions. (TR54-5)
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Design Space
The multidimensional combination and interaction of input variables (e.g., material attributes) and operational parameters that have been demonstrated demonstrated to provide assurance of quality. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval. (TR30) (TR60) (TR 57-2)
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Design Specification
Controlled documentation that clearly and explicitly defines the manufacturing system details, codes, and standards to be followed during fabrication and construction to meet associated requirements. (TR54-5)
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Design, Experimental
The arrangement of factors and factor levels. Optimal experimental design minimizes “noise” in data to allow focus on the influence on assay response of critical factors. A factorial experiment (DOE) may minimize experiments required to achieve analytical purpose. (May be modified with complete block, factorial, fractional factorial, full factorial, incomplete block). (TR57)
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Destructive
A method in which a sample cannot be subsequently utilized in any other analytical method or processed to a final product. (TR86)
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Detectability
The ability to discover or determine the existence, presence, or fact of hazard. (TR54) (TR54-5)
The ability to discover or determine the existence, presence, or fact of a hazard (6). For purposes of this technical report, a hazard typically would be a data integrity breach.(TR84)