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Lot means a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits. (Source: 21 CFR 210.3 (b)(10). Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
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