Invalid Test
Laboratory test that, as a result of the laboratory (Phase I) investigation, did not meet the test method requirements and whose results would not be deemed valid. This may also apply to a test which was aborted (e.g. breakdown of isolator during sterility testing). (TR88)
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Invalid Result
Laboratory test result confirmed to be invalid as determined by a laboratory investigation. (TR88)
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Impact Analysis
Determination of how a product failure may extend an investigation “to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy” (10). (TR88)
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Implants
Implants are long-acting dosage forms that provide continuous release of an API for periods of months to years. They are administered by the parenteral route. For systemic delivery, they may be placed subcutaneously or, for local delivery, they can be placed in a specific region in the body. (TR79)
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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)
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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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In-Process Observations
Observations or findings that are found during the processing of a product or products.(TR76)
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Interference
The capacity of a substance to affect the quantitation of virus in the assay. (TR47)
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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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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)
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In-vitro Transcribed RNA
A RNA copy synthesized using a double-stranded DNA as template. The RNA polymerases of bacteriophage T7 or SP6 are usually used to perform the in-vitro transcription. (TR50)
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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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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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In-Use Testing (also called In-Situ Testing)
A field study that validates the effectiveness of a disinfecting agent, the trained operators, and the approved operating procedures. (TR70)
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Isolator, Open
A decontaminated unit meeting ISO 5 conditions that provides uncompromised, continuous, isolation of its interior from the surrounding environment. It may transfer air directly to the surrounding environment through openings (e.g., “mouse holes”) that preclude the ingress of microbial contamination. (TR13) (TR22) (TR62)
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Investigator
A clinician scientist taking part in a clinical trial having direct and immediate clinical responsibility for the subject or patient and their treatment with the clinical trial material. (TR63)
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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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Intermediate Precision
The precision within the same laboratory using different analysts, equipment, reagents and/or on different days. (TR33)
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Isolator
An industry-specific separative enclosure. (TR51)
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ISTA: International Safe Transit Association
World-wide organization that supports its membership in designing and developing effective pre-shipment packaging performance standards, guides, and best practices for product distribution. (TR39)
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Isolator, Closed
A decontaminated unit meeting ISO 5 conditions that provides uncompromised, continuous, isolation of its interior from the surrounding environment. Any air exchange with the surrounding environment takes place only through microbially retentive filters. (TR22) (TR62) (TR13)
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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)
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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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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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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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ISO 8
Environmental operating conditions defined in ISO 14644-1, “Cleanrooms and associated controlled environments.” Note: For total particulates, ISO 8 approximates Class 100,000 from the now obsolete Federal Standard 209. (TR62)
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ISO 7
Environmental operating conditions defined in ISO 14644-1, “Cleanrooms and associated controlled environments.” Note: For total particulates, ISO 7 approximates Class 10,000 from the now obsolete Federal Standard 209. (TR62)
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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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Intervention
An aseptic manipulation or activity performed by personnel that occurs within the critical area. (TR22) (TR44) (TR62)
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Irradiation
The process by which an item is exposed to ionizing radiation (typically gamma) to reduce or eliminate bioburden. (TR41)
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Investigational Medicinal Product
A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. (TR29)
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Isolates
Microorganisms that are recovered from a facility. (TR70)
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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)
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In-Use
In the hands of the end user who can be the health professional or the patient. In-Use refers to the time period where product is in the custody of the end user or health care professional. (TR53)
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ISO/IEC
International Organization for Standardization/International Electrotechnical Commision. (TR52)
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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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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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ISO 5
Environmental operating conditions defined in ISO 14644-1, “Cleanrooms and associated controlled environments”. (Note: For total particulates, ISO 5 approximates the Class 100 description from the now obsolete U.S. Federal Standard 2009 and is roughly comparable to Grade A as defined in European GMP Annex 1 – “Manufacture of Sterile Medicinal Products.”) (TR22) (TR62)
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Isolated Intermediate
An intermediate that is obtained as the product after workup of a purification step in the process scheme for the drug substance. The isolation or purification procedure should be part of the validated process. An aliquot of a product that is worked up and/or purified for purposes of characterization does not constitute an isolated intermediate. (TR38)
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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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Incident Management System
Part of the Quality Management System that handles incidents, deviations, excursions, and exceptions in the supply chain. (TR58)
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Identification
Use of an analytical procedure to determine the chemical and biochemical identity of a material. (TR57)
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Incident
Any event that occurs during the shelf life of a product that may have an adverse effect on quality (e.g., temperature excursion, missing temperature monitor when required, shipment time in excess of qualified packout duration, wet/ crushed packaging). (TR58)
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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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Inclusivity
The ability of an assay to detect a target microorganism. (TR33)
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Inoculated Carrier
A carrier upon which a defined number of test organisms have been deposited. (TR51)
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Influent
Fluid that flows into a process step. [Synonym: feed.] (TR26)
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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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IAEA (International Atomic Energy Agency)
An international organization that seeks to promote the peaceful use of nuclear energy and to inhibit its use for any military purpose, including nuclear weapons. (TR55)
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Incoterms
International commerce terms. These are a series of international sales terms, published by the International Chamber of Commerce (ICC), and widely used in international commercial transactions. (TR58)
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