Glossary Terms (Simple List)
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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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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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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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Requalification
Periodic confirmation to demonstrate that equipment performance has not changed from its qualified state. (TR3)
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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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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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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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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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Residue
Chemical or microbiological material remaining on equipment surfaces after a cleaning process. (TR29)
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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)