The extent of testing for a given method is DRIVEN by its intended purpose. A test for appearance will not REQUIRE the same validation experiments and supporting data as a chromatographic assay.

Method validations fall into three categories: Full, Partial, and Cross-Validation:

• Full validation is needed for new methods or when major changes to an existing method affect the scope or critical components.
• Partial validation is PERFORMED on a previously-validated method that has UNDERGONE minor modification. Changes in equipment, solution composition, quantization range, or sample preparation merit partial method validation. Fewer validation tests are generally needed compared to a full validation; they are selected based on the potential EFFECTS of the new changes on method performance and data integrity.
• Cross-validation is a comparison of validation parameters when two or more bioanalytical methods are used to generate data within the same study or across different studies. It can be used as a means of determining inter-method equivalency or assessing inter-laboratory execution of the same method.

The extent of testing for a given method is driven by its intended purpose. A test for appearance will not require the same validation experiments and supporting data as a chromatographic assay.

Method validations fall into three categories: Full, Partial, and Cross-Validation: