Glossary Terms (Simple List)
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Electronic Record
A record used for GMP purposes or for regulatory submission that is stored electronically for the purposes of reproduction, retrieval or archival. (TR48)
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Eluate
Solution (effluent) that flows out of the chromatographic column containing the drug substance. [Synonym: collected product fractions] (TR14)
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Elution
Desorption of a drug substance from a chromatographic column. (TR14)
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Emissivity (?)
The emissivity of the surface of a material is its effectiveness in emitting energy as thermal radiation. This is measured between 0 (zero) and 1 (one); 0 having the ability to reflect all energy, and 1 allowing all energy to pass through it. Glass, for example, has emissivity of 0.91 (smooth, uncoated); aluminium foil has emissivity of 0.03. (TR72)
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Emulsions
A dispersed colloidal system consisting of two immiscible liquid phases generally stabilized with one or more suitable agents. Injectable emulsions are sterile liquid dosage forms of drug substances dissolved or dispersed in a suitable emulsion medium. Injectable emulsions are for parenteral administration of poorly water-soluble drugs. (TR79)
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Enabler
A tool or process which provides the means to achieve an objective (ICH Q10). (TR54)
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End-Of-Production Cells (EOPC)
Cells cultured (under conditions comparable to those used in production) from the MCB or WCB to a passage level or population doubling level comparable to or beyond the highest level reached in production. Note: The ICH term is: “Cells at Limit of invitro Cell Age Used for Production”.
Note: The term as defined in ICH Guidance Q5 D is “Cells at Limit of in vitro Cell Age Used for Production”; also abbreviated as EPC. (TR56) -
Endogenous Virus
A virus that pre-exists in the genome of the cell substrate. (TR71)
A virus that integrates into the genome of the cell substrate. (TR83)
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Endogenous Virus-Like Particles – (e.g., Type C endogenous retroviruses)
Virus-like entity whose genetic material is stably integrated into the germ line of an organism or cell line. Cell lines (notably CHO) may constitutively produce virus-like particles, which are typically noninfectious but still of safety concern. Model retroviruses are generally used as surrogates to measure virus-like particle clearance. (TR41)
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Endospore
A type of spore formed intracellularly by some bacterial genera. (TR51)