Glossary Terms (Simple List)
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Stability
The capacity of a drug substance or a drug product to remain within specifications established to ensure its identity, strength, quality, and purity throughout the retest period or expiration dating period, as appropriate. (TR39)
The chemical/biological fidelity of an analyte in a given solvent/matrix under specific conditions. (TR57)
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Stability Budget
A stability budget considers the results of long-term, accelerated, freeze-thaw, and temperature cycling studies to determine the amount of time out of storage that a drug substance may experience without any significant risk to its quality. Firms have used the idea of a stability budget to assign permissible time out of storage for packaging and labeling operations for refrigerated drug products for some time. This concept has been expanded in the present document to include storage and distribution as well. (TR53)
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Stability Profile
The physical, chemical, biological, and microbiological behavior of a drug substance or drug product as a function of time when stored under the defined environmental conditions of an approved protocol. (TR39)
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Stability-Indicating Analytical Method
A test procedure that is able to discern changes in an analyte due to degradation processes. It is capable of accurately measuring changes in the product that can occur under conditions of physical or chemical stress. (TR57)
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Staked Needle
Nonremovable, fixed needle attached to syringe body/cone with adhesive. (TR73)
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Stakeholder(s)
Any individual, group or organization that can affect, be affected by or perceive itself to be affected by a risk. Decision makers might also be stakeholders. For the purposes of this guideline, the primary stakeholders are the patient, health-care professional, regulatory authority, and industry (ICH Q9). (TR54) (TR54-2)
Any individual, group, or organization that can affect, be affected by, or perceive itself to be affected by a risk. Decision makers might also be stakeholders. (TR54-5)
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Standard Deviation
<p>The statistical measure of the dispersion of the data. (TR57) </p> -
Standard Pressure
A pressure of 1 atmosphere (14.70 psi or 760 mm of mercury) to which measurements of quantities dependent on pressure are often referred. (TR45)
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State of Control
A condition in which the set of controls consistently provides assurance of continued process performance and product quality. (TR57)
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Static (at rest)
BFS machine line with conveyor belts at rest but with air shower and room ventilation in operation, extruder (heated, not running) and mold carriage in standby. No operating personnel present. (TR77)