Risk Acceptance
The decision to accept risk (ISO Guide 73). (TR54) (TR54-2) (TR58)
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Restricted Access Barrier System (RABS)
RABS are aseptic processing systems (ISO 5) intended to substantially reduce human borne contamination within the aseptic environment where sterile product, containers, closures and equipment are exposed by the use of separative devices and defined mechanical features and operating procedures. (TR22) (TR62) Aseptic processing systems (ISO 5) intended to substantially reduce human-borne contamination within the aseptic environment where sterile product, containers, closures, and equipment are exposed by the use of separative devices and defined mechanical features and operating procedures. (TR13)
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Receiving Unit (RU)
Term for the internal or external recipient or site where the technology is being transferred to. (TR65)
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Replicates
Independent preparations of a sample or standard that are subject to the same treatment conditions. (TR57)
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Regression
A mathematical model in which the response of a dependent variable is a function of change in an independent variable, such as is seen in a concentration-response curve. Regression may be linear (e.g., a straight line) or non-linear (e.g., four parameter logistic). (TR57)
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Reportable result
The final analytical result. This result is defined in the written approved test method and derived from one full execution of that method, starting from the original sample. (TR57)
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Residual Risk
Risk remaining after risk control measures have been taken. (TR44) (TR58)
Risk remaining after risk control measures have been implemented (derived from ISO 14971:2007). (TR54) (TR54-2)
Risk remaining after risk control measures has been implemented. (TR54-5)
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Ready-To-Use
A marketing term often used to describe the benefits of single-use technology or SUS. This designation has no regulatory or scientific basis supporting suitability for use and the end user is responsible to evaluate and determine if appropriate quality requirements are met for their application. (TR66)
Washed and sterilized components supplied in a package suitable for transfer into an aseptic processing area and used with sterile injectable products without further processing. (TR85)
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Reefer Container
Refrigerated shipping container for transporting perishables, having its own stand-alone (selfpowered) cooling system. (TR54-2)
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Risk Decision
A determination of acceptance or rejection of risk. (TR54) (TR54-2) (TR54-5)
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Resistance Temperature Detector(s) (RTDs)
Resistance temperature detectors are temperature sensors in which the electrical resistance in the element increases with increases in temperature. This electrical resistance is then translated into a temperature value (expressed as a resistance versus temperature curve). (TR48)
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Recalls
Actions taken by a firm to remove a product from the marketplace; may be conducted on a firm’s own initiative or in response to an FDA request or order under the agency’s statutory authority. (TR67)(TR88)
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Recovery Medium
A microbial growth medium that has been validated for the germination of spores and the growth of vegetative cells. Such a medium should be optimized for the growth and germination of injured cells or spores. (TR51)
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Regeneration
Operation performed to remove residual proteins, impurities, or contaminants from the resin. [Synonym: strip] (TR14)
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Reverse Osmosis (RO)
A membrane-based filtration process in which the membrane rejects salt from solution. Pore size is not entirely meaningful for reverse-osmosis membranes, as pores are often not observable by microscopic methods. Reverse osmosis is used to desalinate water. (TR15)
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Risk
The combination of the probability of occurrence of harm and the severity of that harm.(TR30) (TR44) (TR54) (TR54-2) (TR54-4) (TR58) (TR67) (TR68) (TR88)
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Recovery
The mass of desired solute in the final product solution (either permeate or retentate, depending on the process), divided by the mass of the desired solute in the initial feed solution, expressed as a percentage. [Synonym: yield] (TR15) (TR45) A measure of the amount of analyte carried through the entire sample preparation and assay procedure and expressed as a percentage of the nominal concentration. (TR57)
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Risk Analysis
The estimation of the risk associated with the identified hazards. (TR13) (TR30) (TR44) (TR54) (TR54-2) (TR58) (TR54-5)
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Reverse Transcriptase PCR (RT-PCR)
A technique for amplifying a defined segment of a RNA molecule. The RNA is first reverse-transcribed into complementary DNA (cDNA), followed by amplification of the cDNA using PCR. (TR50)
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Reporter Gene
A coding sequence linked to a gene or promoter of interest. It is generally used to determine activation of the promoter or expression of the gene of interest in a cell or organism. (TR50)
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Rejection
The ability of a filter to exclude solutes or particulate matter from passing through. (TR45)
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Repeatability
The precision under the same operating conditions over a short interval of time. (TR57)
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Risk Assessment
A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of identification of hazards and the analysis and evaluation of risk associated with exposure to those hazards. (TR30) (TR44) (TR54) (TR58) (TR55) (TR67) (TR57-2) (TR54-5) (TR88)
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Retention Factor
One minus the ratio of filtrate concentration of component i (Ci,f) to the bulk or feed concentration of component i (Ci,b) as in the following equation:R = 1 - [Ci,f/Ci,b]Where R=0 for a freely passing solute R=1 for a solute that is fully retained by the membrane[Synonym: rejection coefficient, rejection factor] (TR15)
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Reprocessing
Introducing an intermediate or API, including one that does not conform to standards or specifications, back into the process and repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation, filtration, chromatography, milling) that are part of the established manufacturing process. (TR74)
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Recovery Study
A laboratory study combining the sampling method and analytical method to determine the quantitative recovery of a specific residue for a defined surface. (TR29) A laboratory study combining the sampling method and analytical method to determine the quantitative recovery of a specific residue for a defined surface. (TR49)
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Ready for Filling
Prepared for loading with the pharmaceutical product. (TR73)
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Reduction
The act of making changes to reduce risk. (synonym: mitigation) (TR44)
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Resistometer
Test device designed to create defined combinations of the physical and/or chemical variables of a sterilization process. Resistometers were formally called biological indicator evaluator resistometer (BIER) vessels. The resistometer is used primarily in the laboratory to determine D and z-values. [Synonym: BIER Vessel] (TR30) (TR51)
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Retentate
The concentrated feed solution after removal of filtered liquid through the membrane and into the filtrate. [Synonym: concentrate] (TR15)
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Requalification
Periodic confirmation to demonstrate that equipment performance has not changed from its qualified state. (TR3)
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Redundant Filtration
A type of serial filtration in which a second sterilizing-grade filter is used as a backup in the event of an integrity failure of the primary sterilizing filter. (TR26)
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Retention Efficiency
The percentage of particles of a specific size that are removed by a filter. (TR45)
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Risk Mitigation
Active systematic steps taken to reduce or limit risk. (TR55) (TR67)
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Residue
Chemical or microbiological material remaining on equipment surfaces after a cleaning process. (TR29)
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Retailer
A “retailer” buys goods or products in large quantities from manufacturers or importers, either directly or through a wholesaler, and then sells smaller quantities to the end-user. Examples of retailers that sell pharmaceutical products are pharmacies and hospitals. (TR58)
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Risk Control
Items in place and/or actions to implement risk management decisions. (TR44)
Actions implementing risk management decisions. (TR54-2) (TR54-5) (TR84)
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Retrospective Process Validation
Validation of an existing manufacturing process that occurs by reviewing data from relevant historical and test production records. (TR14) (TR42)
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Recipient Related
A microorganism that, due to its numbers and pathogenicity, can cause infection, allergic response or toxemia in patients receiving the product. (TR67)
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Reserve/Reference Samples
An appropriately identified reserve sample that is representative of each lot of intermediate product and in each shipment of each active ingredient shall be retained (at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications; this is a regulatory Requirement). (TR56)
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Retroviruses
RNA viruses containing a virally-encoded reverse transcriptase enzyme able to transcribe the RNA genome into DNA, which can then be incorporated into the host DNA. (TR47)
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Reduction Factor
The viral clearance capacity of a particular unit operation. It is typically calculated as the log10 (virus input ÷ virus output). (See also log titer reduction or log reduction value.) (TR41)
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Resistance Temperature Drive
Sensors that exploit the predictable change in electrical resistance of some materials with changing temperature. (TR3)
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Retention Rating
The means by which a filter manufacturer defines the ability of a filter to retain specific-sized particles. (TR45)
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Reverse Logistics
The process of planning, implementing and controlling the efficient, cost-effective flow of raw materials, in-process inventory, finished goods and related information from the point of consumption to the point of origin for the purpose of recapturing value or proper disposal. (TR46)
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Relevant Virus
A virus used in process evaluation studies that either is the identified virus, or of the same species as the virus known to or likely to contaminate the cell substrate or any other reagents or materials used in the production process. (TR41)
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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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Saturated Steam Process
A sterilization process, typically used for porous/hard goods loads, where the sterilizing medium is saturated steam. (TR01)
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Scalability Studies
Studies used to assess sizing for the appropriate performance of filter media at increased process volumes. (TR45)
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Same
Agreeing in kind, amount; unchanged in character or condition. (TR38)
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