EU method validation

Finally, to avoid the parallel use of similar but not identical method validation studies to fulfil the registration requirements, e.g., of the EU, US Environmental Protection Agency (EPA) or Japanese authorities, an adaptation of different data requirements for residue analytical methods for post-registration control and monitoring purposes would help to save resources. 

Once the determinative or confirmatory method has been developed to take full advantage of the chemical properties of the analyte molecule, a study is necessary to prove that the method is valid. Criteria for method validation are outlined in guidelines from the US FDA, US EPA, and EU. A summary of the differences in regulatory requirements for method validation is provided in Table 3. The parameters addressed by all of the regulatory guidelines include accuracy, precision, sensitivity, specificity, and practicability. 

Table 3 Comparison of US FDA, US EPA, and EU Committee for Veterinary Medicinal Products (CVMP) method validation requirements...

European Commission (2007) Method validation and quality control procedures for pesticide residues analysis in food and feed. SANCO/2007/3131, available from ec.emopa.eu... 

It is generally recognized and accepted that analytical methods must be suitable for the intended use. Furthermore, EU Directives 85/591/EEC, 89/397/EEC and 93/99/ EEC state that analytical procedures for compliance testing with food laws are to be carried out on the basis of validated methods. Method validation is known as the process used to confirm that a procedure is fit for a particular analytical purpose. This process, an essential part of analytical quality assurance, can be described as the set of tests used to establish and document performance characteristics of a method. The performance characteristics of a method are experimentally derived values for the fundamental parameters of importance in assessing the suitability of the method (Horwitz 1988, 1995 Thompson and Wood 1993, 1995 Eurachem 1996 FAO 1998 US EPA 1995 US FDA 1993a). These parameters include ... 

An example of a method validated according to the FDA and EU guidelines is described by Hermo et al.165 These authors used LC-ToF MS to determine the levels of multiresidue antibiotic quinolines in pig livers below the maximum residue limits. They describe the optimization of their method, which is then... 

Method Validation and Quality Control Procedures for Pesticide Residues Analysis in Food and Feed, SANCO/10684/2009, Directorate General for Health and Consumers (SANCO), European Commission, Brussels, 2009 (available at http //ec.europa.eu/food/plant/ protection/resources/qualcontrol en.pdf accessed 10/23/10). 

European Medicines Agency (2011), Committee for Medicinal Products for Human Use. Guideline on Bioanalytical Method Validation. Available at http //www. ema.europa.eu/docs/en GB/document hbrary/Scientific guidehne/2011/08AVC500109686.pdf. 

European Medicines Agency (EMA) Guideline on Bioanalytical Method Validation [33] Guidance for methods used in pharmacokinetic studies and filed in pharmaceutical applications in the EU... 

European Medicines Agency. Guideline on bioanalytical method validation. EMA. Available at, www.ema.europa.eu/ema/ 2012. 

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