Glossary Terms (Simple List)
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Intermediate Material
The chemical mixture that may or may not have completed the chemistry steps, and thus is not in its final chemical and physical/conformational state, and has not been through final process steps to final drug substance.
Examples in the small molecule world include isolated intermediates, intermediates, and final intermediates.
Examples in the large molecule world include crude protein mixtures (pre-transformation, conversion, or folding) and purified protein prior to any final polishing steps. (TR38) -
Intermediate Precision
The precision within the same laboratory using different analysts, equipment, reagents and/or on different days. (TR33)
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Intermodal Container
A shipping container used to ship cargo through more than one of the four traditional modes of transportation (road, air, ocean, and rail). (TR64)
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Internal Control
A reaction performed to provide confirmation of adequate performance of the NAT assay including preparation of nucleic acid, its amplification using appropriate amplification technology, and analysis of amplified products. An example is the amplification of a housekeeping gene from the production cell line which provides a positive signal even in the absence of contaminant DNA. (TR50)
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International Standards Organization (ISO) Container
ISO containers are shipping containers manufactured according to specifications from the International Standards Organization. They may also be referred to as “sea containers” or “inter-modal” containers. (TR46)
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Intervention
An aseptic manipulation or activity performed by personnel that occurs within the critical area. (TR22) (TR44) (TR62)
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Intervention, Corrective
An intervention that is performed to correct or adjust an aseptic process during its execution. Examples include such activities as: clearing component misfeed, adjusting sensors, and replacing equipment components. (TR22) (TR62)
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Intervention, Inherent
An intervention that is an integral part of the aseptic process and is required for set-up or routine operation and/or monitoring, e.g., aseptic assembly, container replenishment, environmental sampling, etc. Inherent interventions are required by batch record, procedure, or work instruction for the proper conduct of the aseptic process. (TR22) (TR62)
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Intraperitoneal (i.p.)
Term defines when a chemical is administered through the peritoneal cavity (area that contains the abdominal organs). (TR55)
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Intrinsic Particles
Those particles that arise from sources related to the formulation, packaging, or assembly processes. In each of these cases, the particle material (e.g., glass, stainless steel, rubber, or gasket material) could be identified as a known product-contact material. (TR78)
A particle that comes from within the primary process. These are qualified product contact materials and are often associated with the primary packaging components. They are unplanned but not unexpected.(TR85)