Glossary Terms (Simple List)
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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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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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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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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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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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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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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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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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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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Risk Acceptance
The decision to accept risk (ISO Guide 73). (TR54) (TR54-2) (TR58)