Guides

Different organizations have composed their own guidelines about validation of single laboratory analytical methods. The most important validation guides are listed below.

Implemented in VaLChrom (partially/fully):

• Eurachem analytical method validation
• ICH (International Conference on Harmonization) validation study requirements for tests used to support drug approval submission
• EMA (European Medicines Agency) bioanalytical method validation

Planned to be implemented:

• IUPAC (International Union of Pure and Applied Chemistry) single-laboratory validation of analytical methods
• AOAC International single-laboratory validation of analytical methods
• FDA (The United States Food and Drug Administration) bioanalytical method validation
• NordVal validation of proprietary chemical methods (test kits)
• SANTE/11813/2017: Guidance document on analytical quality control and method validation procedures for pesticide residues and analysis in food and feed