《《Validation of Analytical Methods and Procedures- Dr. Ludwig Huber》.docx

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2015-10-03 发布于河南
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《《Validation of Analytical Methods and Procedures- Dr. Ludwig Huber》.docx

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?Green (11) gave a practical guide for analytical method validation, with a description of a set of minimum requirements for a method. Renger and his colleagues (12) described the validation of a specific analytical procedure for the analysis of theophylline in a tablet using high-performance thin layer chromatography (HPTLC).? The CITAG/ EURACHEM guide (19) includes a chapter on how to treat non-routine methods.? The principles of diode-array detection in HPLC and their application and limitations with regard to peak purity are described in the literature (21) The AOAC manual for the Peer-Verified Methods program (15) includes a table with estimated precision data as a function of analyte concentration (Table 4). Validation of Analytical Methods and Procedures Author:? HYPERLINK / Dr. Ludwig Huber Frequent speaker and chair person at FDA, ISPE, PDA, USP. IVT, and GAMP conferences and workshops Introduction ? Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice. Analytical methods need to be validated or revalidated before their introduction into routine use; whenever the conditions change for which the method has been validated (e.g., an instrument with different characteristics or samples with a different matrix); and whenever the method is changed and the change is outside the original scope of the method. ? Method validation has received considerable attention in the literature and from industrial committees and regulatory agencies. The U.S. FDA CGMP (1) request in section 211.165 (e) methods to be validated: The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accorda