Glossary Terms (Simple List)
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Penicylinder
A small, ceramic carrier surface used to hold cultures of microorganisms. Used in antimicrobial effectiveness testing procedures. (TR70)
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Performance Attribute
An output variable or outcome that cannot be directly controlled but is a measurable indicator that the process performed as expected (e.g., bioburden, load monitor). [Synonym: performance parameter] (TR30)
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Performance Indicator
An output variable or outcome that cannot be directly controlled but is an indicator that the process performed as expected. (TR60-3)
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Performance Qualification (PQ)
Documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications. (TR3) (TR14) (TR45) (TR42) (TR48) (TR61) (TR64)
Transport tests of product or representative product that is conducted during actual transportation or distribution. (TR39)
Documented evidence that provides a high degree of assurance that the equipment and/or system functions accurately and consistently according to predetermined specifications in its operating environment. (TR54-5)
Documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications (17). (TR60-3)
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Perimeter
Measured length of the outer edges of a particle.
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Periodic Requalification
Re-execution of qualification studies performed on a periodic basis to verify that systems and processes remain able to produce a result that consistently meets predetermined acceptance criteria through execution of a lab or field study. (TR54-5)
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Periodic Review
A documented review of pertinent data as appropriate (for example, manufacturing performance trend data, change history, deviation history) to confirm that a process/method/system continues to consistently produce a result meeting predetermined acceptance criteria. (TR54-5)
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Permeability
The degree to which a fluid will pass through a permeable substance under specified pressure and temperature conditions. (TR41) (TR26)
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Permeate
The fluid which passes through a membrane. (see also filtrate) (TR41)
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Pesticide
Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest. Any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant and any nitrogen stabilizer. (TR70)