Glossary Terms (Simple List)
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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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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 Materials
Starting materials, reagents, and solvents used in the production of intermediates or APIs/drug substance. (TR54-4) (TR83)
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Ready for Filling
Prepared for loading with the pharmaceutical product. (TR73)
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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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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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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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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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Receiving Unit (RU)
Term for the internal or external recipient or site where the technology is being transferred to. (TR65)