Glossary Terms (Simple List)
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Odor Threshold
The lowest concentration of a compound detectable to 50% of the people tested. (TR55)
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Ongoing Process Verification (OPV)
A formal plan to assure the process remains in its validated state during routine (post-PPQ) production and the process remains in a state of control (2, 3). (TR60-3)
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Online Observations
Observations or findings that are found during the processing of a product or products. (TR43)
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Open System
(See system, open) (TR28)
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Operating Characteristic Curves
The operating characteristic curve shows the probability of acceptance (Pa) for any level of lot quality. (TR43)
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Operating Parameters
Values (e.g., time, temperature, pressure) that are controlled and/or measured that collectively define each phase of a sterilization cycle (e.g., heat-up, exposure, cool-down). (TR01) (TR3) (TR48) (TR61)
An input variable (e.g., time, temperature, pressure) or condition of the manufacturing process that can be directly controlled. (Synonym: process parameter) (TR30) (TR51)
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Operating Parameters (Critical Parameters)
Values that are controlled and/or measured and are linked to safety and efficacy of a product or the process. Failure to meet a critical parameter should result in rejection of the load. (TR01) (TR3) (TR48) (TR51)
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Operating Parameters (Key Parameters)
Values that are controlled and/or measured and are used to assure the ongoing “state of control” and consistency of runs. Failure to meet a key process parameter should result in an investigation with a documented rationale for the disposition of the load. (TR01) (TR3) (TR51) (TR48)
Values that are controlled and/or measured and are used to assure the ongoing “state of control” of steam in place cycles. Failure to meet a key process parameter should result in an investigation. (TR61)
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Operating Principle
Rules or concepts governing the operation of the system. (TR38)
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Operational Qualification (OQ)
Documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges. (TR14) (TR61) (TR64) (TR72)
The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges. (TR54-5)
Documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges (17). (TR60-3)