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- W2010414458 abstract "Compliance with GMPs is expensive. Additional capital equipment and staff are required. Are, then, all of these controls necessary? Does the benefit to the public of compliance with GMPs outweight or even equal the added cost of the device? The answer has to be yes. Environmental control can greatly reduce random bacterial contamination of tissue culture products and culture media and this, in turn, can reduce the risk of a lost patient specimen. Such controls can also reduce the likelihood of cross contamination of commercially prepared antigens, and because all productions follow DMR, controls can insure a greater degree of product consistency than would be the case without the control. As a practical example, a recent article reported a pseudooutbreak of influenza A associated with the use of a laboratory stock virus strain (3). Apparently, while fluorescent antibody test slides were being prepared with stock influenza A virus, cell cultures or cell culture reagents were contaminated with the stock virus. The result was false virus isolation from 11 patients' viral cultures. GMPs are designed to prevent this type of mishap during manufacturing. The user laboratory's assurance that the manufacturing process was under control rests in the statement. “For in Vitro Diagnostic Use.”" @default.
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- W2010414458 date "1986-02-01" @default.
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- W2010414458 title "The significance of “For in vitro diagnostic use”" @default.
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- W2010414458 doi "https://doi.org/10.1016/0196-4399(86)90105-4" @default.
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