Test Sets
A group of defect standards combined with good or blank units used to evaluate the probability of detection in visual inspection or testing system performance. Test sets can be used for inspector training, validation of automated systems, or other special studies as needed. (TR79)
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Tyndall Lighting
Collimated lighting at right angle to the viewing direction, typically against a black or dark background, which is useful during manual visual inspection to detect fine dispersions of small particulate that scatter the light making them more detectable. (TR79)
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Technically Unavoidable Particles (TUPs)
Particles that are visibly different from the bulk of the material when viewed with the naked eye within the container or against a suitable background (e.g., size, shape, color, number, texture) and are inherent to the manufacturer’s process, product, or raw materials. The unintended presence of a small quantity of particles, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, or migration from packaging that is technically unavoidable in good manufacturing practice, and do not pose a risk to patient safety. (TR78)
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Tailgate Sample
Representative and random samples of the lot taken by the manufacturer during the packing process for the use of incoming inspection purposes. (TR76)
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True Copy (WHO)
A true copy is a copy of an original recording of data that has been verified and certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record including, in the case of electronic data, all essential metadata and the original record format as appropriate.(TR80)(TR84)
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True Copy (FDA)
21 CFR 211.180(d) requires records to be retained "either as original records or true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records". Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original or raw data, which includes associated metadata and the static or dynamic nature of the original records.(TR80)(TR84)
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True Copy (MHRA)
A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure as the original.(TR80)(TR84)
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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
Temperature is the measure of thermal energy. (TR01)
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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-Controlled Distribution
Material handling and movement of goods from an origin site to a receiving site, where the goods are kept within a specified temperature range using active and/or passive systems. (TR58)
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Temperature Probe/Sensor
A generic term used to describe any type of temperature measuring device that works through contact with the material or atmosphere to be measured. [Synonyms: Load Probe, Heat Penetration Probe, Temperature Distribution Probe, Drain Probe] (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)
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Temperature Probe
A sensor (e.g., thermocouple or resistance temperature detector (RTD)) that has been specifically designed to measure temperature. Temperature probes may be control, resident, surface mounted, validation, mapping, or permanent. (TR61)
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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 Monitor
A unit that measures the prevailing temperature. Several types exist, including: • Stationary monitors installed in (cold) storage warehouses or storage facilities; • Mobile monitors that include: • Chemical indicators that change color when exposed to temperature over time • Electronic indicators that indicate temperature excursions, but provide little or no summary data • Electronic or mechanical data loggers that record and store temperature data for retrieval after arrival • Transmitting monitors that transmit near real-time data and excursion events using wireless/satellite interfaces and software for “logical analysis” of data. (TR58)
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Temperature Sensitive Products
Products whose quality may be adversely affected by temperature extremes (e.g., frozen, refrigerated, and certain controlled room temperature products). (TR39)
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Temperature-Controlled Ocean Container
An actively cooled metal box, most commonly 20 or 40 foot long which can be easily transferred between different modes of transportation, such as ships, trains and trucks. Sometimes it is called a reefer container or intermodal container. (TR58)
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Temperature-Controlled Ocean Container (Reefer, Intermodal Container)
An actively cooled metal box (commonly 20 or 40 ft long) that can be easily transferred between different modes of transportation, such as between ships, trains, and trucks. (TR64)
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Temperature Profile
Anticipated ambient temperature variation and duration to which product may be exposed during transportation. (TR39)
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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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Transfectoma
Cells expressing exogenous proteins or reporter genes, produced by the transfection of continuously growing cells with gene expression constructs. (TR50)
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Throughput
The amount of solution that passes through a filter, described as volume per membrane area. [Synonym: capacity.] (TR15) The amount of solution that passes through a filter. It is described as volume through the membrane area. [Synonym: capacity] (TR26)
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Thumb Pad
Disk at end of plunger rod. (TR73)
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Toxicity Studies (also referred to as “Tox” studies)
In vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions with the primary goals of identifying the following: 1) an initial safe dose and subsequent dose escalation schemes in humans; 2) potential target organs for toxicity and for the study of whether such toxicity is reversible; and, 3) safety parameters for clinical monitoring after the appropriate dosing and administering schedule is followed (relevant to the drug being studied). In toxicity studies, the test animals are examined by histological or serological methods in order to identify toxic, mutagenic, or teratogenic effects of the drug. It is sometimes possible to collect physiological data from the animals prior to sacrifice. Some toxicity studies may be performed using cell culture methods. Toxicity studies are also described by the U.S. FDA as “nonclinical laboratory studies” and by ICH as “preclinical safety evaluations”.
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). (TR56)
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Transmission Electron Microscopy (TEM)
A microscopy technique whereby a beam of electrons is transmitted through an ultra-thin specimen, interacting with the specimen as it passes through it. An image is formed from the electrons transmitted through the specimen, which are magnified and focused by an objective lens, and appear on an imaging screen. (TR41)
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Tissue Culture Infectious Dose – TCID50
The dilution of virus that results in the probability of infection of 50% in replicate tissue-culture inoculations. (TR41)
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Titer Reduction (TR)
A measure of the degree to which a particular filter removes a microorganism under specified test conditions. Calculated as the ratio of the total number of microorganisms used to challenge the filter divided by the total number of microorganisms that passed through the filter. (TR75)
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Transport Service Provider
Contracting party who mediates or executes the transportation of medicinal products on behalf of the shipper. (TR39)
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Temperature-Controlled Truck or Trailer
A cargo box attached to a truck chasse or as a trailer pulled by a truck that is equipped with a temperature control unit (TCU) to provide active cooling or heating control inside the box. Refrigerated trucks or trailers are sometimes referred to as “reefers”. The temperature control units are typically powered by an integrated engine or gen-set and not the engine that is used to propel the truck. (TR58) A cargo box attached to a truck chassis or consisting of a trailer pulled by a truck that is equipped with a TCU to provide active cooling or heating control inside the box (refrigerated trucks or trailers are sometimes referred to as “reefers”). (TR64)
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Transcription-Mediated Amplification (TMA)
An isothermal NAT method that can amplify RNA or DNA targets a billion-fold in less than one hour. TMA technology uses two primers and two enzymes: RNA polymerase and reverse transcriptase. (TR50)
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Transportation Service Providers (TSP)
Companies that physically transport the product. (TR52)
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Trend Analysis
Analysis of environmental data over time indicating a shift; adverse trends require investigation. (TR70) A review performed in response to an alert or action condition. This review provides an analysis of specific environmental monitoring data to identify adverse trends.(TR13)
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Tub
Plastic box that contains a vertically oriented syringe nest and is sealed with a lid. (TR73)
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Terminal Sterilization
A process whereby product is sterilized within its sterile barrier system. (TR01 The application of a lethal agent to sealed, finished drug products for the purpose of achieving a predetermined sterility assurance level (SAL) of usually less than 10-6 (i.e., a probability of a nonsterile unit of less than one in a million). A process where the material is sterilized in its final packaged configuration. (TR13)
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Two One-Sided T-Test
A method for declaring the comparability of equivalence that is built around comparing two or more group means and their respective mean difference confidence intervals against predetermined equivalence limits. (TR57-2)
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Transition Analysis
Mathematical evaluation of the chromatogram tracing as the mobile phase changes from one solution to another. An alternative to HETP and peak asymmetry for evaluating column packing and performance. (TR14)
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Transport Service Agreement
A contractual agreement that describes the legal, logistical, technical and quality terms or contractual arrangements between shippers and transport services providers. Different names might be used for this type of agreement in different companies. (TR39)
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Tertiary Packaging Component
A component that is used to assemble secondary or primary packages in the form of the basic transportation unit and to provide protection against mechanical impact. Examples are corrugated cardboard boxes, but corresponding plastic boxes/containers are also used. (TR39)
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Transportation Study
Study performed to generate data to evaluate the effect of temperature variation on the product during transportation on product quality. Other test, such as vibration, pressure, and drop tests, may be considered. (TR39)
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Touchdown PCR
A technique to reduce appearance of non-specific amplicons in PCR reactions. The earliest cycles of a touchdown PCR method have high annealing temperatures. The annealing temperature is decreased in increments for subsequent cycles until a fixed point is reached. (TR50)
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Turbidity
Finely dispersed particles causing cloudiness or haziness in water or other fluid. Turbidity may be measured using a nephelometer. (TR45)
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Titer
The concentration of infectious virus calculated, taking into account the dilution factor. (TR41)
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Test Article
Any food additive, color additive, drug, biologically derived product, etc., for human use or any other article subject to regulation. “Test Article,” in this report’s context, referring to the samples used for toxicity and stability studies. (TR56)
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Turbulent Flow
Movement of a fluid in which its velocity at any point varies in a random or erratic (nonlaminar) manner. (TR69)
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Total Impurities
The sum of all impurities observed. (TR38)
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Thermal Mass
The mass of material present multiplied by that material’s specific heat capacity. (TR64)
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Toxicity
The capacity of a substance to confer morbidity or mortality. In the context of virus assays, the ability of a buffer or other process components to kill or otherwise harm the functionality of indicator cell lines. This is independent of the infection by the virus. (TR41)
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Transmembrane Pressure (TMP)
The pressure difference equal to the average feed-stream pressure minus the average filtrate-stream pressure. TMP = (Pfeed + Pretentate)/2 - Pfiltrate (TR15)
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The Last Mile
This is a multidimensional cross-industry term that defines a point in the supply chain where the product or service directly faces the customer, end user or patient. (TR46)
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