Glossary Terms (Simple List)
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In-Process Method (In-Process Control)
Checks performed during production to monitor and, if appropriate, adjust the process to ensure that the intermediate or active pharmaceutical ingredient conforms to its specifications. (TR57-2)
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In-Process Observations
Observations or findings that are found during the processing of a product or products.(TR76)
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Inspection by Attributes
An inspection where either a unit of product is classified as conforming or nonconforming or the number of nonconformities in the unit of products is counted with respect to a given requirement or set of requirements (TR76)
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Installation Qualification (IQ)
Documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations, and/or user requirements. (TR14) (TR42) (TR48) (TR61) (TR64)
The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations. (TR54-5)
Documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations, and/or user requirements (17). (TR60)
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Integrity Test
Test to determine the functional performance of a membrane filter or container/closure system. (TR22)
A nondestructive test used to predict the functional performance of a filter. (TR45)
A nondestructive physical test that can be correlated to the bacterial retention capability of a filter/filter assembly. (TR26)
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Integrity Testing
A method of determining if a membrane or filter is physically intact and free from gross defects. (TR15)
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Intended Use/Intended Purpose
Use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer. (TR54)
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Interference
The capacity of a substance to affect the quantitation of virus in the assay. (TR47)
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Intermediate
A material produced during steps of the processing of a drug substance that undergoes further molecular change or purification before it becomes a drug substance. (TR14) (TR74)
A material produced during steps of the processing of a drug substance that undergoes further molecular change or purification before it becomes a drug substance (17). (TR60) -
Intermediate (or In-Process Material)
A material produced during the steps of the processing of an API that undergo further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (TR60)