Microbial Data Deviation
A microbial test result that deviates from approved specifications or in-process limits. (TR88)
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Maximum Allowable Leak Limit (MALL)
The greatest gap or leak rate that does not put product quality at risk (2). (TR86)
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Mitigation
Systematic steps taken or in place to reduce or limit the identified risk. (TR84)
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Microdosing Studies
Studies designed to speed up the development of promising drugs by establishing early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. May include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent’s pharmacokinetics and pharmacodynamics. A Microdosing study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. (TR56)
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Manufacturing System Lifecycle
All phases in the life of a manufacturing system from the initial development until the manufacturing system retirement, including specification design, fabrication, installation, commissioning, qualification, operation, maintenance, change, decommissioning and retirement. (TR54-5)
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Manufacturing System
The term system or systems represents equipment, facility, critical utilities, instruments, and other entities which perform the process or provide the conditions under which the process is performed. (TR54-5)
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Manual Inspection
Consists of manual handling and presentation of filled containers under controlled conditions of lighting and background to allow for human visual inspection. (TR79)
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Manual Baseline
Data generated from visual inspection of a blinded set of seeded test containers that demonstrates the detection capability of human inspection. The test set is sometimes referred to as a “particle size threshold set,” where various foreign particulate types in a gradation of sizes are examined to yield a statistically significant probability of detection percentage for each unit. This allows the determination of what types and sizes of particulates can be reproducibly detected in a specific product/container system. (TR79)
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Mandrel
Specialized filling needles on certain BFS machines which also act to form the container. (TR77)
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Measured Values
Those values where activity is confirmed by interpolation from a reference standard curve.(TR82)
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Masking
A type of interference that may result in low endotoxin recovery.(TR82)
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Manual Integration
Process used by a person to modify the integration of peak area by modifying the baseline, splitting peaks, or dropping a baseline as assigned by the chromatography software to overrule the pre-established integration parameters within the chromatographic software.(TR80)
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Metadata (WHO)
Metadata are data about data that provide the contextual information required to understand those data. These include structural and descriptive metadata. Such data describe the structure, data elements, interrelationships and other characteristics of data. They also permit data to be attributable to an individual.(TR80)
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Metadata (MHRA)
Metadata is data that describe the attributes of other data and provide context and meaning. Typically, these are data that describe the structure, data elements, inter-relationships and other characteristics of data. It also permits data to be attributable to an individual (or if automatically generated, to the original data source).(TR80)
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Metadata (FDA)
The contextual information required to understand data. A data value is by itself meaningless without additional information about the data. Metadata is often described as data about data. Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data.(TR80)
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Microbial By-Products
An analytical procedure that yields numerical results compared to quantitative specification(s). (TR57) Organic compounds produced by microorganisms during metabolism and released into the bulk-phase environment. (TR69)
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Microorganism
A microbe; a free-living organism too small to be seen by the naked eye. (TR45) (TR26)
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Microbial Count Determination
A test performed to quantify the number of microorganisms present in a sample of material. Standard microbial methods are utilized to estimate the number of colony forming units (CFU) per unit mass or volume. (TR28)
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Microbial Classification
The arrangement of microorganisms into taxonomic groups based on their similarities and relationships. (TR13)
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Method, Quantitative
An analytical procedure that yields numerical results compared to quantitative specification(s). (TR57)
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Microbial Characterization
The description of microorganisms based on their cellular morphology, Gram reaction, and key diagnostic tests (e.g., Gram-positive coagulase-negative cocci). (TR13)
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Micro-condensation
The formation of very fine layers of condensation often invisible to the naked eye. (TR51)
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Microbiological Identification
Biochemical characterization of isolated colonies to determine the isolate genus and, where feasible and appropriate, the species. (TR22)
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Microbiological Examination Tests
The compendial tests for microbial enumeration and absence of specified microorganisms as found in USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumerations Tests and USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. (TR67)
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Method, Qualitative
An analytical procedure, based on the characteristics of a material that yields results that are not amenable to reliable enumeration. (TR57)
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Microfiltration (MF)
Pressure-driven, membrane-based separation process in which particles and dissolved macromolecules (typically 0.1 &mum or larger) are retained. (TR15)
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Microbial Enumeration
Compendial test for microbial counts using the plate-count, membrane-filtration or most probable number methods described in USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumerations Tests. (TR67)
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Microbial Identification
The determination of the genus, and species when possible, to which a laboratory or manufacturing isolate belongs. (TR13)
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Minimum Acceptable Cycle (MAC)
The minimum cycle conditions (in terms of delivered minimum lethality or minimum time and temperature) that would be considered acceptable. (TR01) (TR61)
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Multiplicity of Infection (MOI)
The average number of infectious units added per cell in an infection. (TR41)
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Monodispersed particles
Particles of uniform size in a dispersed phase. In the case of viruses, this term refers to free virus particles not agglomerated to other viruses or proteins in solution. (TR41)
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Mixed Load
A load that contains multiple item item types representing various sterilization challenges. For example, some load items may have air removal challenges, while others pose a challenge due to their mass. (TR01)
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Moist Heat Sterilizer
Equipment (e.g., a pressure-rated vessel and associated controls) used to achieve sterilization through time, temperature and pressure. [Synonym: Autoclave, Steam Sterilizer] (TR48)
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Mock Soiling
A process of soiling the equipment for a cleaning validation protocol in which soil is applied to the equipment surfaces to simulate the condition of the soil on those surfaces following typical product manufacturing. (TR29)
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Module
An individual unit consisting of multiple membranes in any format within a frame structure containing integral channels and ports for feed, retentate, filtrate and air connections. (TR15) Filter element that is incorporated into a cartridge or capsule. (TR26)
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Moist Heat
Steam, steam-air mixtures, and superheated water used for sterilization. (TR01)
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Minimum Load
The minimum quantity or mass of items permitted in a validated depyrogenation or sterilization load. (TR01) (TR3) (TR30) (TR48)
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Microprocessor
One of the five major components of a TCU, the unit interfaces with temperature sensors in the discharge and return air and adjusts the output rate of active cooling or heating to achieve the setpoint temperature. (TR64)
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Mycoplasma Reduction Filter
A sterilizing grade filter that also provides a log reduction value (or a titer reduction value) for a specified test mycoplasma according to the PDA Mycoplasma Consensus Method. (TR75)
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Most Probable Number (MPN) Method
A statistical method of estimating the number of viable organisms suspended in a liquid. (TR51)
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Mollicutes
A class of bacteria which lack a cell wall. Mollicutes are small, typically about 0.1-0.5 &mum in size, and vary in form (trivial name: mycoplasma) (TR50)
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Multi-Use System (MUS)
An engineered process equipment solution for process management and unit operations designed for repeated use. (TR66)
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Microorganism of Concern
A bacterium, yeast, or mold that, due to it prominence in product recalls, infection outbreaks, nosocomial infections, and the clinical literature, results in a multifactor risk assessment to determine whether the microorganism is objectionable if it is present in a specific nonsterile product. (TR67)
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Mock Soil
A soil which is used in place of the manufactured product during a cleaning validation protocol (also called a “surrogate” soil). (TR29)
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Moisture Content of Wood
The moisture content of wood is calculated by the following formula: Moisture content = (Mg-Mod)/Mod. Where Mg is the green mass of the wood and Mod is its oven-dry mass (the attainment of constant mass generally after drying in an oven set at 103 ± 2 °C for 24h). The equation can also be expressed as a fraction of the mass of the water and the mass of the oven-dry wood rather than a percentage. For example, 0.59 kg/kg (oven-dry basis) expresses the same moisture content as 59% (oven-dry basis). (TR55)
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Mycoplasma
Small, flexible bacteria that lack a cell wall. Mycoplasma can pass through 0.2 μm and some 0.1 μm rated filters and are unaffected by some antibiotics, such as penicillin. (TR70) (TR47)
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Method Validation
A formal, archived demonstration of the analytical capacity of an assay that provides justification for use of the assay for an intended purpose. (TR56)
A formal, archived demonstration of the analytical capacity of an assay that provides justification for use of the assay for an intended purpose. Validations are conducted prospectively according to a written, approved plan that states acceptance criteria. (TR57) (TR57-2)
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Matrix
The combination of materials (e.g., excipients, stabilizer components, etc.) which are components together with the measured analyte. (TR57)
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Membrane
A thin, microporous medium used to remove particles and microorganisms from a fluid stream under pressure. (TR26)
Analytical technique to collect particles from a liquid sample on a membrane filter followed by manual examination (sizing and counting) with a microscope. (TR85)
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Medium
In filtration, the porous material which retains particles as a fluid passes through during the process of filtration (TR26)
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