Glossary Terms (Simple List)
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Parameters (Non-Key Operational Parameter)
An input process parameter that has been demonstrated to be easily controlled or has a wide acceptable limit. Non-key operational parameters may have an impact on drug substance quality or process performance if acceptable limits are exceeded. (TR14)
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Parameters (Non-Key Process Parameter (Non- KPP; Synonym – Non-key Operational Parameter) )
An input parameter that has been demonstrated to be easily controlled or has a wide acceptable limit. Non-key operational parameters may have an impact on quality or process performance if acceptable limits are exceeded. (TR60)
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Parameters (Operational Parameter)
An input variable or condition of the manufacturing process that can be directly controlled in the process. Typically, these parameters are physical or chemical (e.g., temperature, process time, column flow rate, column wash volume, reagent concentration, or buffer pH). [Synonym: process parameter] (TR14)
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Parameters (Performance Parameter)
An output variable or outcome that cannot be directly controlled but is an indicator that the process performed as expected. [Synonym: performance attributes] (TR14)
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Parameters (Process Parameter (Synonym – Operational Parameter)
An input variable or condition of the manufacturing process that can be directly controlled in the process. Typically, these parameters are physical or chemical (e.g. temperature, process time, column flow rate, column wash volume, reagent concentration, or buffer pH). (TR60)
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Parametric Release
A sterility release system based upon effective control, monitoring, documentation, and batch records review of a validated sterilization process cycle in lieu of release procedures based upon end-product sterility testing. (TR01) (TR3) (TR13)
A sterility release program based on effective control, monitoring and documentation of a validated sterile-product manufacturing process where sterility release is based on demonstrated achievement of critical operational parameters and performance attributes in lieu of end-product sterility testing. (TR30)
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Parison
The “tube” of polymer extruded by the BFS machine from which the containers are formed. (TR77)
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Part per Billion (ppb)
1 part in 1 x 109 total parts. Can be measured in mass/mass (e.g., 1 nanogram/gram) or in volume/volume (e.g, 1 nanoliter/liter). (TR55)
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Part per Trillion (ppt)
1 part in 1 x 1012 total parts. Can be measured in mass/mass (e.g., 1 picogram/gram) or in volume/volume (e.g, 1 picoliter/liter). (TR55)
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Partial-Cycle Qualification
A qualification method that uses less than the full exposure time to demonstrate sterilization or sanitization cycle efficacy. [Synonym: fractional cycle.] (TR61)