By Chung Chow Chan, Y. C. Lee, Herman Lam, Xue-Ming Zhang
Validation describes the techniques used to research pharmaceutical items in order that the knowledge generated will agree to the necessities of regulatory our bodies of the U.S., Canada, Europe and Japan. Calibration of tools describes the method of changing, checking or correcting the graduations of tools so they agree to these regulatory our bodies. This e-book presents an intensive rationalization of either the elemental and useful points of biopharmaceutical and bioanalytical tools validation. It teaches the correct techniques for utilizing the instruments and research tools in a regulated lab environment. Readers will study the ideal strategies for calibration of laboratory instrumentation and validation of analytical equipment of study. those strategies needs to be done thoroughly in all regulated laboratories, together with pharmaceutical and biopharmaceutical laboratories, scientific trying out laboratories (hospitals, scientific workplaces) and in nutrition and beauty trying out laboratories.
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Additional info for Analytical Method Validation and Instrument Performance Verification
Accuracy for the area percent method should be established from 50% of the ICH reporting limit to the nominal concentration of drug substance in the sample solution. For the high–low and external standard methods, determine accuracy from 50% of the ICH reporting level to 150% of the proposed shelf life specification of the related substances. In addition, for the area percent and high–low methods, it is necessary to determine the accuracy of the related substances and the drug substance. For the external standard method, only the accuracy of related substances is required.
Sample preparation procedure (shaking time, different membrane filters) c. HPLC solution stability Other Considerations. Typically, the variations in robustness results are compared to the intermediate precision results to demonstrate that robustness is not affected significantly within normal day-to-day variation. When the related substance results are affected by some critical experimental parameters, a precautionary statement needs to be included in the procedure to ensure that this parameter is tightly controlled between experiments.
Since solutions of different concentration are prepared separately from different weights, if the related substances reach their solubility limit, they will not be completely dissolved and will be shown as a nonlinear response in the plot. However, this is not suitable to prepare solutions of very low concentration, as the weighing error will be relatively high at such a low concentration. In general, this approach will be affected significantly by weighing error in the preparation. Another approach is to prepare a stock solution of high concentration, then perform serial dilution from the stock solution to obtain solutions of lower concentrations for linearity determination.
Analytical Method Validation and Instrument Performance Verification by Chung Chow Chan, Y. C. Lee, Herman Lam, Xue-Ming Zhang