Glossary Terms (Simple List)
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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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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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Marker
Component of a product or a cleaning agent used as an analyte to quantitate the total amount of product or cleaning agent present. (TR29)
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Market Action
Voluntary withdrawal, recall or notification to patients, consumers or physicians of marketed pharmaceutical or consumer healthcare products for compliance or safety reasons. (TR55)
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Market Package
The package presentation intended for the end user (e.g., bottle + cap liner + screw cap + label + dose cup + carton; may contain multiple units of product), but not including packaging used solely for transportation (e.g., corrugated boxes or insulated containers). (TR39)
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Masking
A type of interference that may result in low endotoxin recovery.(TR82)
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Mass Spectroscopy
An analytical test method for identifying the chemical composition of a sample by separating its gaseous component ions according to their mass and charge. (TR26)
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Master Cell Bank (MCB)
The MCB represents a collection of cells of uniform composition derived from a single source prepared under defined culture conditions. (TR 54-4)
The MCB represents a collection of cells of uniform composition derived from a single source prepared under defined culture conditions, aliquoted into multiple vials, cryopreserved and stored in the vapor phase of liquid nitrogen. (TR 83)
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Master Cell Bank (mCb)/Master Virus Bank (mVb)
A stock of cells or virus used to produce the Working Cell Bank or the Working Virus Bank. Cell/virus banking is used to enhance biological consistency. (TR47)