Setting Specifications and Investigating Out-of-Specification Results

Authored by: Michael E. Swartz , Ira S. Krull

Handbook of Analytical Validation

Print publication date:  April  2012
Online publication date:  April  2012

Print ISBN: 9780824706890
eBook ISBN: 9781420014488
Adobe ISBN:

10.1201/b12039-7

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Abstract

Specifications establish the criteria to which a drug substance or a drug product should conform to be considered acceptable for its intended use. Setting specifications requires justifications, and the application of different types of tests under different circumstances, each with their own acceptance criteria.

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