Analytical methods

Hosmoticsrl also offers services of development and validation of analytical methods based on chromatographic, spectrophotometric and mass spectrometry techniques, in accordance with the main international validation procedures.

Method validation has received considerable attention in the literature and from industrial committees and regulatory agencies. The U.S. FDA CGMP 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 accordance with Sec. 211.194(a). These requirements include a statement of each method used in testing the sample to meet proper standards of  accuracy and reliability, as applied to the tested product. The U.S. FDA has also proposed industry guidance for Analytical Procedures and Methods Validation.

In Europe ISO/IEC 17025 includes a chapter on the validation of methods with a list of nine validation parameters. The ICH has developed a consensus text on the validation of analytical procedures. The document includes definitions for eight validation characteristics. ICH also developed guidance with detailed methodology.