Glossary Terms (Simple List)
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Meaningful Disruption
A meaningful disruption is a change in production that is reasonably likely to lead to a reduction in the supply of a drug by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product. A meaningful disruption is not an interruption in manufacturing due to matters such as routine maintenance and does not include insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time. (TR68)
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Measured Values
Those values where activity is confirmed by interpolation from a reference standard curve.(TR82)
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Media
The part of the filter through which fluid passes that retains particles during filtration. (TR45)
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Media Fill
See Aseptic Processing Simulation. (TR22)
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Medically Necessary Drug
Any drug product used to diagnose, treat, or prevent a serious disease or medical condition for which no other drug is judged to be an appropriate substitute or there is an inadequate supply of an acceptable alternative as determined by the relevant health authority. (TR68)
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Medicinal Product
Any product intended for the diagnosis, treatment, or prevention of disease. (TR39)
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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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Melting Temperature (Tm)
The calculated or observed temperature for a primer/nucleic acid mixture at which 50% of primer-binding sites are in single strand form. (TR50)
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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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Membrane (Synthetic)
A finely porous structure having lateral dimensions much greater than its thickness, through which mass transfer may occur by the application of driving forces like pressure or electro-osmotic. (TR15)