Glossary Terms (Simple List)
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Target Product Profile (TPP)
A format for a summary of a drug development program described in terms of labeling concepts to facilitate communication regarding a particular drug development program. (TR60) (TR60-2)
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Targeted Species
The range of species for which detection or analysis is aimed for by an assay method. (TR50)
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TCld50 Assay
Quantal assays for determining the titer of a virus. The 50% tissue culture infective does (TCID50) is the dilution of virus that results in the infection of 50% of cell cultures that have been infected with the same dilution of the virus sample. (TR47)
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Technical Diligence
The means by which the technical capabilities of the SUS, its supplier and its fit with the end user are verified. It is complimentary to a quality audit program and becomes a recurring theme over the implementation process and subsequent routine procurement. (TR66)
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Temperature
Temperature is the measure of thermal energy. (TR01)
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Temperature Control Unit (TCU)
A unit that controls the refrigeration and heating systems. It typically contains a microprocessor and thermostat to maintain the set temperature. (TR64)
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Temperature Controlled
The sequence of transportation events, from the manufacturer of the API up to the receipt of the final packaged product by the end user, which maintains temperature sensitive products within approved temperature specifications. Maintaining temperature control during these transportation events assures that product quality is maintained. (TR39)
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Temperature Distribution
Temperature measurement of the heating medium (e.g., forced hot air) across the chamber load zone. (TR01) (TR03) (TR30) (TR48)
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Temperature Excursion
Any event in which product is exposed to temperatures outside of the recommended storage and/or transport temperature range. (TR39)(TR58)