Glossary Terms (Simple List)
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Needle-Safety Device
A safety feature or mechanism that effectively reduces the risk of an exposure incident (e.g., accidental needlestick). (TR73)
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Negative Control
A test article used to assess the performance of an assay in the known absence of a targeted microorganism or nucleic acid. Negative controls are used to minimize a risk of false positive results, which could occur due to non-specific signals. (TR50)
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Nest (Tub Nest)
Rigid plastic support placed into a tub to keep syringes upright with sufficient separation to allow for easy manipulation by manual or automated fill-line systems. (TR73)
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New Drug Application (NDA)
An application filed with the FDA used for the regulation and control of new drugs in the United States; the goal is to provide enough information to permit the FDA reviewer to reach the following key decisions: whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks; whether the drugs proposed labeling (package insert) is appropriate, and what it should contain; whether the methods used in manufacturing the drug, and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity. (TR56)
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Nominal Molecular-Weight Cutoff (NMWCO)
A manufacturer’s measure of an ultrafiltration membrane based on a defined solute-retention coefficient. (TR15)
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Nominal Pore Size Rating
A filter rating with an arbitrary value, indicating a particulate size range at which the filter manufacturer claims the filter removes some percentage. Nominal ratings vary from manufacturer to manufacturer and may not be suitable to compare filters among manufacturers. Processing conditions, such as operating pressure and concentration of contaminant may have a significant effect on the retention efficiency of the nominally rated filters. (TR41)
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Nominal Value
The assumed activity of an endotoxin preparation, dilution, or "spike"; based on label-claim information.(TR82)
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Nonclinical Laboratory Study
For this report, nonclinical laboratory study means in vivo or in vitro experiments, in which test articles are studied prospectively in test systems under laboratory conditions in order to determine their safety. The definition does not include: studies using human subjects or clinical studies, field trials in animals, or any basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics as described in ICH S6 and 21 CFR Part 58 (GLP).
Note: Also referred to as Preclinical, Toxicity or “Tox” studies. (TR56) -
Non-Condensable Gases
Air and other gases that will not condense to liquid state, thereby not releasing latent heat under the conditions of sterilization. (TR01)
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Nonconformity (ANSI def.)
A departure of a quality characteristic from its intended level or state that occurs with severity sufficient to cause an associated product or service not to meet a specification requirement. [Synonym: Defect] (TR43)(TR76)