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The USP is published in a combined volume with the National Formulary (a formulary) as the USP-NF. [2] If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation "USP" or "NF".
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21 C.F.R. 211.110 (a)(6) states that bioburden in-process testing must be conducted pursuant to written procedures during the manufacturing process of drug products. [3] The United States Pharmacopeia (USP) outlines several tests that can be done to quantitatively determine the bioburden of non-sterile drug products.
During the review process, the submitted data undergoes verification to ensure compliance with Good Laboratory Practice (GLP) standards. Additionally, the GLP compliance status of the testing facility where the study was conducted is assessed by referring to inspection information from national GLP compliance monitoring programs.
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Image:BlankMap-World.png – World map, Robinson projection centered on the meridian circa 11°15' to east from the Greenwich Prime Meridian. Microstates and island nations are generally represented by single or few pixels approximate to the capital; all territories indicated in the UN listing of territories and regions are exhibited.
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