Self test 1 – Validation of liquid chromatography mass spectrometry (LC-MS) methods

1. A new person is employed in your lab and she will replace a colleague in doing certain analyses. Does this require any changes concerning validation?

Yes, the methods should be validated from scratch.

Yes, new data for important validation parameters should be collected and compared/pooled with the existing data.

No, method parameters do not need to be determined again after the validation has been completed once by the previous employee.

2. Who may be interested in the results of the method validation?

Legal bodies

Customer

Lab staff

Accreditation body

3. You are developing a method to identify traces of explosives in various forensic samples after burning. Which of these (in addition to possibly other) performance parameters are crucial to be determined during validation:

Limit of detection

Linearity

Trueness

Selectivity/Specificity

4. Organize the parameters according to a reasonable sequence of determination during validation:

First	Trueness Unselect Linearity Unselect Stability Unselect
Second	Trueness Unselect Linearity Unselect Stability Unselect
Third	Trueness Unselect Linearity Unselect Stability Unselect