Method validation reports

B. Richter, J. EzzeU, and D. Felix, Single Laboratory Method Validation Report Extraction of Organo-phosphorus Agrochemicals, Chlorinated Herbicides and Polychlorinated Biphenyls Using Accelerated Solvent Extraction (ASE) with Analytical Validation by GC/NPD and GC/ECD, Document 101124, Dionex Sunnyvale, CA (1994). 

Knowledge based only Method, method validation report related knowledge and target specifications None None Updated training record... 

A detailed method validation report may not be necessary until submission of the final market application. However, summary reports should be available to facilitate efficient data retrieval and fulfill requests from regulatory agencies for the information when required. 

A specific, detailed description of the bioanalytical method should be written. This can be in the form of a protocol, study plan, report, and/or standard operating procedure (SOP). All experiments used to make claims or draw conclusions about the validity of the method should be presented in a report (method validation report). 

History and rationale for the development of all major non-compendial methods for excipients and the finished product. List of all applicable reports supporting method development (e.g., method validation reports, technical support documents, etc.). 

List of all applicable reports supporting method development (e.g., method validation reports, technical support documents). 

Finally, to the best of our knowledge, there are, as yet, no analytical method validation reports for the assay of the latest TKIs pazopanib, bafetinib, cediranib, and motesanib in human biological samples. 

The validation report should contain reference to the analytical methods (specific code number used as identifier within the pharmaceutical organization) and the corresponding drug substance or product name. Note that for early-phase method validation reports the results maybe filled in a predefined table and compared against the acceptance criteria. However, for late-phase validation, more explicit reports are generated explaining each and every experiment, with detailed steps of sample and standard preparation. 

TABLE 12.1 Bioanalytical Method Validation Reports Recommended Contents... 

As in the method validation report, the bioanalytical report should include sufficient details to allow an evaluation of the method and its performance under the actual conditions of sample analysis. It is understood that most bioanalytical methods are... 

If a lack of accuracy is not due to assay performance (i.e., analyte instability or interconversion) then the reason for the lack of accuracy should be investigated and its impact on the study assessed. The extent and nature of these experiments is dependent on the specific sample being addressed and should provide sufficient confidence that the concentration being reported is accurate. The results of incurred sample reanalysis studies may be documented in the final bioanalytical or clinical report for the study, and/or as an addendum to the method validation report . 

Method validation report of HPLG limit test for potential leachables from foil laminate overwrap, Analytical Test Report, Dey L.P., Napa CA., USA. 

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