Glossary Terms (Simple List)
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Opportunistic Pathogens
Microorganisms responsible for infection in injured, invasively treated or immune-suppressed individuals that typically do not cause infection in healthy individuals, unlike frank pathogens. (TR67)
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Opportunity Costs
This is defined as the value of the next-best choice available when choosing between several mutually exclusive choices (e.g., the decision to expand a facility may result in losing the opportunity to invest the maintenance funds in the financial markets). Opportunity costs are often excluded from estimates of fixed operation costs because they can be difficult for comparative analyses in the overall decision process. (TR66)
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Optical Density (OD)
A unitless measure of the absorption of light of a given wavelength in media of a given path length. (TR41)
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Organohalogens
The major organohalogens or organic compounds containing chlorine, bromine or iodine of interest are halophenols and haloanisoles, especially 2,4,6 tricholorophenol (TCP), 2, 4, 6 tribromophenols (TBPs), 2, 4, 6 trichloroanisole (TCA), and 2, 4, 6 tribromoanisole (TBA). (TR55)
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Original Record (MHRA)
The first or source capture of data or information, e.g., original paper record of manual observation or electronic raw data file from a computerised system, and all subsequent data required to fully reconstruct the conduct of the GXP activity. Original records can be static or dynamic.(TR80)
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Outlet Pressure
The pressure exiting the downstream side of the filter. [Synonym: effluent or downstream pressure] (TR26)
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Out-of-Level Result (Out-of-Limit Result)
Any unexplained deviation or result that failed to meet set levels for environmental monitoring and other utilities. (TR88)
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Out-of-Specification Result
Any unexplained deviation or the failure of a pharmaceutical ingredient, drug substance, or drug product batch to meet any of its regulatory-release and shelf-life specifications. (TR88)
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Overkill Design Approach
A sterilization design approach where minimal information is required about the product bioburden. A worst-case bioburden assumption is used to determine the delivered lethality needed to achieve a PNSU of 10-6 on or in the items being sterilized. When using this approach, the qualification program must demonstrate that both the FBIO and FPHYS are greater than 12 minutes. The required lethality may vary regionally. (Note: For typical SIP systems, the FPHYS will need to be greater than the FBIO.) (TR01) (TR3) (TR30) (TR61)
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Over-the-Counter (OTC) Drug Products
Drug products sold in drug stores directly to customers without a physician’s prescription. (TR67)