Glossary Terms (Simple List)
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Animal-Derived Raw Materials (Secondary)
Non-animal in origin but may be derived from processes that include materials from animal components that come in direct contact with the raw material, for example, a recombinant protein produced in an E. coli fermentation that uses fermentation medium containing tryptone, or a recombinant protein expressed in plants that are exposed to bovine manure fertilizer. (TR83)
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Animal-Derived Raw Materials (Tertiary)
Sourced from synthetic components but includes animal-derived components used during the manufacture of the raw material that do not come in direct contact with the raw material, for example, polymers or elastomers used in process equipment or plumbing that may contain or may have been exposed to animal-sourced materials such as stearates or slip agents. (TR83)
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Anisotropic (Asymmetric) Membrane
A membrane in which the pore size and structure differ from one face to the other. These membranes are usually considered “directional” because of the difference in flow characteristics, depending on which surface of the membrane faces the feed stream. (TR15)
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Annealed
Controlled heating process used to remove residual thermal stress from glass containers after glass forming. [Synonym: Lehred] (TR43)
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Annealing Temperature
A temperature designed to allow primers to attach to single-stranded DNA or RNA to initiate amplification. The annealing temperature is usually kept a few degrees lower than the melting temperature of the primers to avoid non-specific amplification. See “Melting Temperature”. (TR50)
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Annual Product Review
GMP-mandated evaluation of the standards for each active pharmaceutical ingredient (API), drug product or biologics to determine the need for changes in drug product specifications and/ or manufacturing, control procedures or manufacturing processes. (TR54-5)
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Antimicrobial Chemical Agent
Substance used to destroy or suppress the growth of microorganisms, whether bacteria, fungi, or viruses, on inanimate objects and surfaces. (TR70)
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AOAC International (Association Official Analytical Communities)
Serves communities of the analytical sciences by providing the tools and processes necessary to develop voluntary consensus standards or technical standards through stakeholder consensus and working groups in which the fit-for-purpose and method performance criteria are established and fully documented. (TR55)
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Archival (MHRA <Archive>)
A designated secure area or facility (e.g., cabinet, room, building or computerised system) for the long-term retention of data and metadata for the purposes of verification of the process or activity.(TR80)
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Archival (WHO)
The process of protecting records from the possibility of being further altered or deleted, and storing these records under the control of independent data management personnel throughout the required retention period.(TR80)