Supplements to the PQRI Workshop Results - Pharmaceutical Technology

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Supplements to the PQRI Workshop Results

Pharmaceutical Technology


Where an official product purports to conform to the standards of the USP- NF the manufacturer must assure that each batch conforms to each monograph requirement. This assurance must be achieved by appropriate means, including process validation and controls and end product testing. Therefore, in some cases it may not be necessary for a manufacturer to test each batch for each monograph requirement.

Sec. 420.500 - Interference with Compendial Tests (CPG 7132a.01)

A compendial drug product containing an added substance which interferes with the compendial assay of the product would be adulterated under 501(b) of the Act.


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