Analytical methods regulatory guidance documents

In recent years, the International Conference on Harmonization (ICH) has published two documents that serve as expert guidance on analytical and related validation [53,54], As part of the outsourcing process, the client and provider should review these and related regulatory guidances (e.g cleaning validation) to ensure that there is a mutual understanding and agreement on the scientific basis of methods validation. 

CCRVDF, and also evaluating the suitability of analytical methods for these residues. Two aspects are considered by JECFA with respect to the performance of analytical methods (1) JECFA must ensure that methods used in the pharmacokinetic and residue depletion studies considered in the establishment of an ADI or recommendation of MRLs are suitably validated to support the quality of the data reported in these studies, and (2) JECFA has been asked by CCRVDF to recommend when a suitably validated analytical method is available for regulatory use to support the recommended MRLs. JECFA has published a guidance document that states the requirements for validation of analytical methods submitted for JECFA consideration. " ... 

The extent of validation required will depend on the nature of the intended analytical outcomes. Is the method quantitative (i.e., to allow a measure of quantity of some characteristic of the sample, whether it be active ingredient, impurities, or excipient) or is the method simply a determination of what is present (qualitative) In the forensic environment, both qualitative and quantitative data will most likely be required therefore, it is advisable to ensure that the validation covers both aspects. The extent to which validation is conducted and the parameters that should be included have been the subject of several guidance documents produced by a variety of industrial committees and regulatory or advisory bodies. 

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