This section addresses the analytical methods used to detect cleaning residues and confirms that these methods are capable of measuring residues at defined acceptance limits.
1. Purpose and Definition Quantitative method capability defines the ability of an analytical method to measure residue levels accurately and precisely across a defined range. In cleaning validation, it ensures that reported values reflect the true amount of residue present…
1. Purpose and Definition Specificity and selectivity define the ability of an analytical method to measure the target residue accurately in the presence of other substances. In cleaning validation, this ensures that measured results represent the actual residue of interest…
1. Purpose and Definition Detection limits define the lowest amount of residue that an analytical method can reliably detect or quantify. In cleaning validation, they ensure that analytical methods are capable of measuring residues at or below established acceptance criteria….