Glossary Terms (Simple List)
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Rondo Tray
Plastic packaging with a horizontal design used to accommodate syringes during the manufacturing process. (TR73)
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Root Cause Analysis (RCA)
An evaluation conducted for the purpose of identifying the cause of the deviation or non-conformance. (TR52)
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Route of Administration
The way in which a drug product or medical device is delivered based on the dosage form and therapeutic use. (TR67)
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Routine Operational Cycle
Parameters that are specified for ongoing sterilization operations. The operational cycle is typically controlled to produce additional lethality over the qualified minimum acceptable cycle in order to provide increased sterility assurance. (TR01) (TR61)
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Routine Operational Process
Parameters that are specified for ongoing operations. The operational process is typically controlled to produce additional lethality over the qualified minimum parameters (i.e., time and temperature) in order to provide increased sterility assurance. (TR3)
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Ruggedness
The degree of intermediate precision or reproducibility of test results obtained by assessing the same samples under a variety of normal test conditions. (TR33)
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Same
Agreeing in kind, amount; unchanged in character or condition. (TR38)
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Sampling Plan
This indicates the number of units of product from each lot or batch which are to be inspected (sample size or series of sample sizes) and the criteria for determining the acceptability of the lot or batch (acceptance and rejection numbers). (TR43)
The number of units of product from each lot or batch that need to be inspected (sample size or series of sample sizes) and the criteria for determining the acceptability of the lot or batch (acceptance and rejection numbers). (TR 76)
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Sampling Plan True AQL
The quality of product for which the percent of lots expected to be accepted (Pa) is 95.0. These values are found in Tables X-A-1 to X-R-1 in ANSI/ASQ Z1.4.(TR76)
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Sanitization
Reduction of microbial contaminants to safe levels as judged by public health requirements for the specific country. (TR13)
A significant reduction in bioburden, achieved in chromatography by the use of bactericidal agents, such as sodium hydroxide (NaOH), hydrochloric acid (HCl), ethanol (EtOH), and isopropanol (IPA). (TR14)
The process of reducing microbial levels by treatment at less than defined sterilizing conditions. Typically water at 80 °C or a chemical treatment is used to perform sanitization of process components. (TR45)
A process that reduces the number of viable microorganisms to a defined level. (TR61) (TR69)