Glossary Terms (Simple List)
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Probability of a Non-Sterile Unit (PNSU)
The number that expresses the probability of occurrence of a non-sterile unit after exposure to a sterilization process. Within the pharmaceutical industry, a design end point better than or equal to the probability of one non-sterile unit in a million units is expected, i.e., PNSU ≤ 10–6. [Synonym: Steriliy Assurance Level (SAL)] (TR01)
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Probability of Detection
The likelihood of detecting a defective unit during an inspection process expressed as a probability, quantitatively as a number (0–1) or as a percentage (0–100%). (TR79)
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Process
A series of operations and/or actions used to produce a desired result. (TR38)
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Process Analytical Technology (PAT)
A system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. (TR60) (TR60-2)
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Process Characterization
Studies performed during process development to establish acceptable ranges for key input variables and critical operational parameters that define the process design space. (TR56)
A study that evaluates the process to increase process knowledge and examines proposed ranges and their individual and/or combined impact on target protein quality. Process characterization studies include deliberate variation of parameters to determine their effect on product quality attributes, often conducted as small-scale studies. (Also known as process evaluation studies, process justification studies, engineering studies, development studies, robustness studies, or process design studies. (TR60)
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Process Characterization Report
A report that includes results from a study characterizing the performance of a unit operation and/or operations conducted in a process characterization study. The report describes process characteristics, the operational parameters (e.g., critical, key, and non-key) and their acceptable ranges (limits), and acceptance criteria for Validation
protocols. (TR14) (TR42)
A report that includes results from a process characterization study with information on the performance of one or several unit operation(s). The report describes process characteristics, the parameters (e.g., critical or noncritical) and their studied ranges (limits) and may outline acceptance criteria for process performance qualification protocols.(TR60)
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Process Control Parameters
Conditions and corresponding measurements associated with the manufacturing process that may affect the identity, strength, quality, potency, and purity of a product. Examples of parameters of concern include bioburden, process rate, weight, volume, temperature, and pressure. (TR13)
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Process Flow Diagram (PFD)
A document, typically prepared by R&D, that describes the intended manufacturing process. The PFD includes all relevant information for the operation of the manufacturing process, organized by unit operation. The PFD serves as the source document for the initial development of the master production records and is locked down once development has determined that the process can be controlled. (TR65)