Glossary Terms (Simple List)
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Correlation Coefficient ( r )
A measure of covariation, the square root of the coefficient of determination. (TR57)
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Corrugate (also known as cardboard or fiberboard)
A thin, stiff material made of pressed paper pulp or pasted sheets of paper and used, for example, for making cartons or fiberpak drums. (TR55)
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Corruption (Data) (FFIEC)
Errors in computer data that occur during writing, reading, storage, transmission, or processing, which introduce unintended changes to the original data.(TR80)
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Cosmetics
Personal care product formulations used to enhance an individual’s visual appearance or eliminate odor. This broad definition also applies to any material intended for use as a component of a cosmetic product. Note: The FDA specifically excludes soap from this category. (TR67)
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Coupon
A small, generally flat portion of a defined material of construction (such as stainless steel or PTFE) and of a defined surface finish, typically used for laboratory cleaning evaluations and/or for laboratory sampling recovery studies. (TR29) (TR49)
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Co-Validation
Sending and receiving laboratories participate in the AMV study execution. (TR57)
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Coverage
The appropriate distribution of a chemical agent needed on the equipment surface to be effective. (TR70)
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Critical
Describes a process step, process condition, test requirement, or other relevant parameter or item that must be controlled within predetermined criteria to ensure that the drug substance meets its specification. (TR38)
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Critical Area/Critical Zone
An area designed to maintain sterility of sterile materials. Sterilized product, containers, closures, and equipment may be exposed in critical areas. (TR13) (TR22) (TR44) (TR62)
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Critical Aspect Design Elements (CADE)
Critical aspect design elements are components, instruments, and process controls that comprise the critical aspect (e.g., temperature feedback loop). Critical aspect design elements are tested in commissioning and qualification. (TR54-5)