Glossary Terms (Simple List)
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Protocol
A predefined, written procedural method for the design and implementation of experiments to define and document the methodology and criteria required to assess the capability of a temperature-controlled system to achieve the desired result. (TR64)
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Protocol Deviation
A deviation that occurs when a result is unexpected (i.e., fails to meet the predetermined acceptance criteria) or a procedure in the protocol cannot be executed as written (e.g., when a challenge is conducted using a methodology other than that described in the protocol or a process/ piece of test equipment fails). (TR64)
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Protocol Summary Report
A report generated at the completion of the activities identified in an individual validation protocol that summarizes deviations and conclusions. (TR64)
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Proven Acceptable Range (PAR)
A characterized range of a process parameter for which operation within this range, while keeping other parameters constant, will result in producing a material meeting relevant quality criteria. (TR60) (TR60-2)
A characterized range of a process parameter for which operation within this range, while keeping other parameters constant, will result in producing a material meeting relevant quality criteria (8). (TR60-3) -
Psid
Pound-force per square-inch differential is the difference in pressure; for example, the pressure differential between the upstream (influent) and downstream (effluent) sides of a filter. (TR75)
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Psoralen
A class of UV photoactivated chemicals able to covalently modify nucleic acids. Psoralens may be used to reduce contaminating nucleic acid in NAT reagents. (TR50)
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Pyrogen
Any substance capable of eliciting a febrile (or fever) response upon injection or infection (as in endotoxin released in vivo by Gram-negative bacteria. (TR3)
Fever-producing substance (TR69)
A material that elicits a pyrogenic response (fever). (TR70)
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Q-PCR Probe
A synthetic, chemically-labeled single-stranded nucleic acid complementary to a selected sequence within a DNA sequence to be amplified using forward and reverse primers in a Q-PCR reaction. A probe is typically labeled with both a fluorophor and quencher. The latter inhibits fluorescence until the quencher and fluorophore are separated by the exonuclease activity of DNA polymerase. (TR50)
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Qualification
Documented testing that demonstrates with a high degree of assurance that a specific process will meet its pre-determined acceptance criteria. (TR39) (TR58) (TR64)
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Qualification (Equipment and Systems)
Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and will actually lead to the expected results. (TR54-5)