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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Use-related Risk Analysis
A systematic assessment of all of the user steps involved in using the device with particular consideration of the potential use errors, their associated clinical consequences along with the risk-mitigation strategies, and the method of validating the risk-mitigation strategies. (TR73)
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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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Vegetative Cell
Cells in an actively growing state. Some microorganisms can only be vegetative, while others are sporeformers and can be in a vegetative or spore (dormant) state. (TR13)
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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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Viral Removal
Physical separation of virus particles from the intended product. (TR47) (TR83)
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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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Validation Reference Standards
Reference standard preparations used for method validations. (TR50)
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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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Value-added Activities
Includes the management of materials, operations, qualification, verification, vender audits, materials testing, and shop-floor oversight that allows an SUS to be used in operations. (TR66)
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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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Thermocycling
Repetition of the PCR reaction steps of denaturing, annealing, and extension. Each step is characterized by different temperatures and reaction times. Some PCR methods combine the annealing and extension steps (i.e., two step PCR). (TR50)
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Trend
A statistical term referring to the direction or rate of change of a variable(s) (ICH Q9). (TR54) (TR54-2)
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Thermometric Study
The utilization of independent temperature monitoring devices to determine a temperature profile within the load zone and analysis of the collected data. (TR3)
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Viral Inactivation
Reduction of virus infectivity caused by chemical or physical modification. (TR41) (TR83)
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Verification Accredited Wholesale Distributors (VAWD)
An accreditation governed by the U.S. National Association of Boards of Pharmacy for pharmaceutical wholesale distribution facilities indicating that they are in compliance with state and federal laws. (TR52)
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Ultracentrifugation
Subjection of material to an exceedingly high g-force. The technique can be used to band or sediment virus particles. (TR47)
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Ultrafiltration (UF)
A pressure-driven, membrane-based separation process in which a semipermeable membrane is used to retain high molecular weight solutes, while low molecular weight solutes are allowed to pass through the membrane. (TR15)
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Virus (Adventitious Virus)
Unintentionally introduced contaminant viruses. (TR47)
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Validation, partial
A documented prospective study intended to demonstrate suitability for the intended use of previously validated methods, specifically for new products and/or processes. (TR57)
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Total Organic Carbon (TOC)
An indirect measure of organic molecules present in pharmaceutical waters measured as carbon. (TR45) Measurement term for the total organic carbon in a sample. (TR70)
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Toll-like Receptor (TLR)
A class of single membrane-spanning non-catalytic receptors that recognize structurally conserved molecules derived from microbes. They can activate immune cell responses when microbes have breached physical barriers such as the skin or intestinal tract mucosa. (TR50)
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Thermocouple
A device for measuring temperature in which a pair of wires of different metals are joined and the free ends of the wires are connected to an instrument (such as a voltmeter) that measures the electrical potential difference created at the junction of the two metals. (TR3)
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Transfer Disinfection
A disinfection process conducted on materials and equipment that coats the surface for a validated wetted time to remove bioburden prior to introducing such items into classified areas. (TR70)
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Virus (Endogenous Virus
Viral entity whose genome is part of the germ line of the species of origin of the cell line and can be produced in culture by cell lines from these species. (TR47)
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Taints
Taints are unpleasant odors and tastes due to low levels of organic compounds of natural or human-derived origin in food, beverages and drug products. Taints arise from an external source as opposed to off-odors or off-flavors from internal changes to a product (i.e., microbial spoilage). (TR55)
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Tangential Flow Filtration
Filtration in which the product stream is introduced parallel to the membrane surface and flows in a direction perpendicular to the filtrate flow. (Synonym:cross-flow filtration) (TR15)
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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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Target Criteria
Numerical limits, ranges, or other suitable measures of target performance levels of an analytical method that indicate suitable performance for intended use. For a method entering qualification, this is a target performance criterion that, when assessed, indicates that the method is qualified for its intended purpose. (TR57-2)
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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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Tangential or Cross Flow Filtration (TFF or CFF)
Filtration in which a fluid (feed) stream runs tangential to a membrane. A pressure differential causes some fluid to pass through the membrane. (TR41)
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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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Standard Deviation
<p>The statistical measure of the dispersion of the data. (TR57) </p>
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Spore
A bacterial dormant form that is highly resistant to adverse conditions. Fungal spores are not highly resistant; their susceptibilities are closer to vegetative microorganisms. (TR13)
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Specification
A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. (TR14)
A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. Drug product and drug substance specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities (TR38) (TR57)
A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. Drug product and drug substance specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities (TR69)
A list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance, drug product, or materials at other stages of its manufacture should conform to be considered acceptable for its intended use. “Conformance to specification” means that the drug substance and drug product, when tested according to the listed analytical procedures, will meet the acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval. (TR56) (TR74)
A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use (17). (TR60-3)(TR88)
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Stability Budget
A stability budget considers the results of long-term, accelerated, freeze-thaw, and temperature cycling studies to determine the amount of time out of storage that a drug substance may experience without any significant risk to its quality. Firms have used the idea of a stability budget to assign permissible time out of storage for packaging and labeling operations for refrigerated drug products for some time. This concept has been expanded in the present document to include storage and distribution as well. (TR53)
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Specified Microorganisms
Microorganisms with limit tests for absence in 1 or 10 g of a drug product, as described in USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms and USP <1111> Microbiological Quality of Nonsterile Pharmaceutical Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. (TR67)
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Stakeholder(s)
Any individual, group or organization that can affect, be affected by or perceive itself to be affected by a risk. Decision makers might also be stakeholders. For the purposes of this guideline, the primary stakeholders are the patient, health-care professional, regulatory authority, and industry (ICH Q9). (TR54) (TR54-2)
Any individual, group, or organization that can affect, be affected by, or perceive itself to be affected by a risk. Decision makers might also be stakeholders. (TR54-5)
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Sporicidal Vapor Phase Decontamination
The destruction of inactivation of microbial spores using a vapor or gaseous agent. (TR51)
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Steam Heat-treated Wooden Pallets
Pallets in which the wood has been heated to achieve a minimum core temperature of 56 °C (132.8 °F) for at least 30 min. Pallets treated via this method bear the initials HT (heat treated) near the International Plant Protection Convention (IPPC) logo. This is one of the methods required for international shipment. (TR55)
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Single-Use Component (SUC)
An individual part designed to perform a particular function when assembled into a single-use system. (TR66)
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Similar
Having a general likeness. (TR38)
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Site Acceptance Testing
The SAT is a series of tests that are performed as part of commissioning after the unit has been installed in the final location. (TR48)
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Stability
The capacity of a drug substance or a drug product to remain within specifications established to ensure its identity, strength, quality, and purity throughout the retest period or expiration dating period, as appropriate. (TR39) The chemical/biological fidelity of an analyte in a given solvent/matrix under specific conditions. (TR57)
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Steam in Place Cycle
A sequence of defined steps and operating parameters (e.g., time, temperature, and pressure) performed in situ on equipment and/or systems to provide a given sterility assurance level (SAL) or defined sanitization level. (TR61)
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Steam: Plant Steam
Steam of undefined chemical or biological quality produced from a boiler, usually containing boiler additives, without further treatment. [Synonym: Factory Steam, House Steam, Industrial Steam] (TR48)
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Sonication
In the context of this Technical Report, the technique is used for dispersing viruses by use of sound-wave energy. (TR47)
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