Glossary Terms (Simple List)
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Independent Replicates
Two or more measurements or observations that are generated from independently prepared samples and do not affect each other. (TR57)
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Indicator Cells
Cell lines that are used in in vitro assays to detect the presence of viral agents. (TR71)
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Infectious Unit
A measure of quantity of infectious virus. An infectious unit does not necessarily reflect the number of virus particles, as virus preparations also contain noninfectious virus particles and, depending on the cellular host, more than one virus particle may be necessary to infect a cell. (TR47)
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Influent
Fluid that flows into a process step. [Synonym: feed.] (TR26)
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Information-only Tests
Tests that provide data that are collected without pre-established acceptance criteria to further evaluate the process. (TR42)
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Inlet Pressure
The applied pressure entering the upstream side of the filter. [Synonym: influent, upstream or line pressure] (TR26)
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Inoculated Carrier
A carrier upon which a defined number of test organisms have been deposited. (TR51)
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In-Process Control
Checks performed during production to monitor and, if appropriate, to adjust the process and/or to ensure that the intermediate or API (drug substance) conforms to its specifications and/or other defined quality criteria (e.g., limits for bioburden and endotoxin). [Synonym: process control] (TR14) (TR74)
Checks performed during production to monitor and, if appropriate, to adjust the process and/or to ensure that the intermediate or drug substance conforms to its specifications (17) and/or other defined quality criteria (e.g., limits for bioburden and endotoxin). (TR60)
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In-Process Leachables
Chemicals substances that are leached, from product-contact or non-product-contact materials under typical process conditions and could be cleared or sufficiently diluted by downstream processes so as to be undetected as leachables in the final dosage. Alternate Terms: Transient Leachables, Migrant Leachable. (TR66)
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In-Process Material
Any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product (21 CFR 210.3(b)). (TR38)