Glossary Terms (Simple List)
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Concentrate
The concentrated feed solution after the removal of filtered liquid through the membrane and into the filtrate. [Synonym: retentate, retentate solution] (TR15)
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Concentration Factor
The ratio of the initial feed volume to the retentate volume. (TR15)
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Concentration Polarization
A phenomenon in which the concentration of retained solutes increases in the region adjacent to the membrane surface due to limitations in particle transport back into the bulk solution. (TR15)
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Concurrent Process Validation
Validation that occurs during manufacturing of drug substance for batches that can be released and used in a final drug product for commercial distribution based on thorough monitoring and testing of the drug substance batches (1, 17). (TR60-3) -
Concurrent Validation
Validation that occurs during manufacturing of drug substance for batches that can be released and used in a final drug product for commercial distribution based on thorough monitoring and heightened testing of the drug substance batches. (TR42)
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Condenser
Component that removes the heat absorbed by the refrigerant from the compressor and temperature- controlled area. (TR64)
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Confidence Interval
An interval estimate (range of values) of a population parameter, calculated from a random sample of the underlying population. (TR57)
Interval estimate (range of values) of a population parameter calculated from a random sample of the underlying population that represents the likely range in which the true value of the parameter resides. (TR57-2)
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Conformance Batches
Batches prepared to demonstrate when the process operates according to defined ranges of operating parameters and under controlled conditions, meet predetermined quality attributes (sometimes referred to as “validation” batches and demonstration batches). (TR56)
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Conformance Batches/Lots
A pre-determined number of production lots, typically three, that represent the process and are evaluated to demonstrate consistency. [Synonyms: validation, consistency, demonstration lots, qualification lots] (TR14) (TR42)
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Consumables
This refers to items (e.g., SUS, storage bags, tubing, filters, diaphragms, flasks, etc.) that form or are a part of process equipment and are used on a per batch basis. (TR66)