The Birth of the Validation Concept The idea of validation was inspired by the drug-related deaths caused by large-volume injectable drugs in the United States in the 1970s.
The injectable drug in question was sterilized during the manufacturing process and conformed to sterility testing during shipment testing.
The manufacturer shipped the product after confirming that it conformed to testing, but a series of accidents occurred in which patients who were administered this product died.
The cause of the accident was that water contaminated with bacteria was used as cooling water, which caused the inside of the heat-sterilized vial to depressurize, and the contaminated water passed through the gap between the vial and the rubber stopper, contaminating the content liquid.
The shipping test was a sampling test for sterility, which was not conducted on the entire number of vials, and the presence of contaminated vials could not be detected.
From this accident, the U.S. FDA realized the need to not only focus on the quality of the final product, but also to ensure that quality is ensured in the manufacturing process, and decided to incorporate the concept of validation into its regulations.
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