1.3. Scope of validation

It is often unnecessary to carry out a determination of all the possible method performance parameters. Validation involving only some of the performance parameters is called partial validation. If a fully validated (e.g. using a collaborative trial) method is set up in the laboratory, then it is necessary to carry out a so-called verification: verify that a method is able to achieve the published values of performance characteristics. Partial validation is justified when a standard method (e.g. ISO, ASTM) is used, small changes are made to previously validated methods or when methods with a narrow application range are validated. Small changes can include transfer of the method to another laboratory, adding a new matrix, implementing new reagents in sample the preparation, etc. FDA states that in the case of bioanalytical methods, it is sometimes sufficient to determine only trueness and repeatability. The ICH guideline distinguishes between the methods for identification, impurity analysis and assay analysis. Different performance characteristics need to be determined for different types of methods. 

Degree of validation* 

http://www.uttv.ee/naita?id=23305

https://www.youtube.com/watch?v=sHnYshEUtOs

*Video refers to old versions of ISO and SANCO, but it does not have an effect on the content.