Procedure for the approval of equivalent analytical methods

Approval scenarios

a. Equivalent method based on a standardised method (Parameter included, matrix correct)
If the method is derived from a recognised standard, includes the relevant parameter, and is applied to the correct matrix, no need to provide additional documents

b. Equivalent method based on a standardised method (Parameter included, matrix NOT correct)
If the proposed method is based on a standard but does not cover the correct matrix, a document demonstrating spiking recovery will be required.

c. Equivalent method based on a standardised method (Parameter NOT included, matrix correct)
If the proposed method is based on a standard, is applied to the correct matrix, but not include the specific parameter, a document demonstrating repeatability, reproducibility and spiking recovery and a self declaration stating that the parameter can be tested under the scope of the proposed method will be required.

d. Equivalent method based on a standardised method (Parameter NOT included and matrix NOT correct)
If the proposed method is based on a standard, is applied to the correct matrix, but not include the specific parameter, a document demonstrating repeatability, reproducibility and spiking recovery and a self declaration stating that the parameter can be tested under the scope of the proposed method will be required.

e. Equivalent internal method
For internal (non-standardised based) methods, the laboratory must provide a document demonstrating spiking recovery and, where applicable, any Root Cause Analysis (RCA) addressing unsatisfactory recovery. The method must be demonstrated to be applied for the correct matrix, and the analyte must be detectable and quantifiable under the proposed analytical conditions.