Glossary Terms (Simple List)
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Secondary (Working, In-house) Reference Standard
Substance of established quality and purity that is qualified against, and used instead of, the primary reference standard; typically used as a reference standard for routine laboratory analysis. (TR57-2)
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Secondary Packaging Component
A component that is not nor will not be in direct contact with the drug product (e.g., vial seals, overwraps, container labels). The purpose of secondary packaging is to identify, protect, market, and communicate information about the product. Examples of secondary packaging include labels, cartons/folding boxes, and leaflets. (TR39)
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Semiautomated Inspection
Consists of machine-assisted handling and presentation of filled containers to allow for human visual inspection. (TR79)
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Sending Unit (SU)
Term for the internal or external source or originator site of the technology to be transferred. (TR65)
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Senior Management
Person(s) who direct and control a company or site at the highest levels with the authority and responsibility to mobilize resources within the company or site (TR54) (TR54-2)
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Sensitivity
Ability of a method to detect small changes in the quality attribute (e.g., changes in concentration or purity) being measured. (TR57-2)
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Sensory Characteristic
Olfactory sensation, odor threshold and taste threshold or organohalogen. (TR55)
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Sensory Tests
Affective and analytical are two major classifications of sensory tests. Affective tests determine consumer response to products, while analytical tests measure the perceived sensory attributes of products. Affective tests are usually commissioned by market researchers and include preference and hedonic (liking) tests to compare products. These tests support product launch decisions, and product positioning, including advertising. Analytical tests are used in the evaluation of product differences and similarities under controlled laboratory conditions to identify and quantify perceived sensory characteristics. Analytical tests include discrimination tests, grading tests, ratings by expert tasters, and descriptive methods such as the flavor profile. The descriptive methods have the greatest applicability to the development of palatable pharmaceuticals. The ASTM International Committee E-18 on Sensory Analysis of Products and Materials publishes a set of standard practices, guidelines and methods. (TR55)
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Separative Enclosure
Device using constructional and dynamic means to create assured levels of separation between the inside and outside of a defined volume. [Synonym: Separative Device] (TR51)
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Serial Filtration
Filtration through two or more filters of the same or decreasing pore size, one after the other. (TR26)