Right First Time
The percentage of the time that a manufacturing process step, batch record, or in-process or laboratory test is successfully completed on the first attempt. (TR88)
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Rect A
The longest side length when a rectangle is constructed around the particle. (TR85)
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Ready-to-sterilize (RTS)
Washed components supplied in a package suitable for sterilization prior to use with sterile injectable products. (TR85)
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Requirements Traceability Matrix (RTM)
The RTM traces requirements to IQ/OQ and/or PQ (also known as User Acceptance Test), configuration, design, procedures, policies, and/or user manuals. (TR54-5)
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Reference Standard Endotoxin (RSE)
The primary standard from USP, EDQM, JP and WHO for use in the harmonized compendial bacterial endotoxins test (BET). The current 3rd International Standard (WHO), USP, and EDQM RS are lyophilized formulation that contains highly purified LPS that is chemically extracted and purified from E. coli strain O113:H10:K(-) and further formulated with stabilizers and excipients.(TR82)
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Raw Data (MHRA)
The original record (data) which can be described as the first-capture of information, whether recorded on paper or electronically. Information that is originally captured in a dynamic state should remain available in that state.(TR80)
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Raw Data (FDA)
Any laboratory worksheets, records, memoranda, notes, or exact copies thereof that are the result of original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study. Raw data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.(TR80)
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Reference Strain
A well characterized, widely accepted preparation of viable organisms that is used to validate a microbiological assay. (TR50)
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Reagent
For analytical procedures, any substance used in a reaction for the purpose of detecting, measuring, examining, or analyzing other substances. (TR57)
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Risk Management
The systematic application of quality management policies, procedures and practices to the tasks of assessing, controlling, communicating and reviewing risk. (TR44) (TR54) (TR54-2) (TR55) (TR67) (TR54-5)
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Relative Accuracy
Attribute determined after demonstration of precision, linearity, and specificity under deliberately varied conditions, such as across a range of sample dilutions in the presence of matrix interference. (TR57-2)
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Retentate Pressure
The pressure measured at the outlet (retentate) side of the tangential flow filter device containing unfiltered material. (TR15)
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Residual Fit
Signed difference between an observed value and the fitted value used to detect nonlinearity, unequal variances, and outliers. (TR57-2)
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Risk Management Report
Report that summarizes the outcomes of the QRM process. (TR54) (TR54-2) (TR54-5)
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Rework
Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent). (TR74)
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Registration Stability Lots
The lots of drug substance manufactured to establish the stability profile in support of the regulatory filing. (TR56)
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Retain (Retention) Samples
Intermediate and final and finished product samples that are stored for the intent of repeating any in-process or release analysis. Typically this is twice the amount of material that is required to perform these. (TR56)
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Risk Evaluation
The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk (TR30) (TR54-2) (TR44) (TR58) (TR54-5)
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Risk Communication
The sharing of information about risk and risk management between the decision maker and other stakeholders. (TR44)
The sharing of information about risk and risk management between the decision maker and other stakeholders. (TR54-2) (TR54-5)
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Reference Standard
A characterized biological material developed to monitor the performance of an assay. For example, the standards for NAT assays may be nucleic acid templates such as plasmids, genomic DNA, cellular or in vitro synthesized RNA. (TR50) The defining characteristics of a reference standard are: 1) it is stable; 2) it performs similarly (e.g., on dilution) to test materials in the assay; and 3) it is homogeneous. (TR57) A reference standard, or reference material, is a substance prepared for use as the standard in an assay, identification, or purity test. It should have a quality appropriate to its use. It is often characterized and evaluated for its intended purpose by additional procedures other than those used in routine testing. For new drug substance reference standards intended for use in assays, the impurities should be adequately identified and/or controlled, and purity should be measured by a quantitative procedure. (TR63)
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Revalidation
Repeating partial or full validation of a process after a process change is implemented. Re-validation is change-based, not time-based. (TR14) (TR3) (TR42)
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Risk Identification
The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description.(TR44) (TR54-2) (TR58) (TR54-5)
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Reproducibility
The precision among multiple laboratories (collaborative studies, usually applied to standardization of methodology). (TR57) The precision between laboratories, for example, through collaborative studies. (TR33)
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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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