TeAM YYeP G Digitally signed by TeAM YYePG DN: cn=TeAM YYePG, c=US, o=TeAM YYePG, ou=TeAM YYePG, email=yyepg@msn.com Reason: I attest to the accuracy and integrity of this document Date: 2005.04.26 20:58:03 +08'00' [...]... Method Validation and Instrument Performance Verification, Edited by Chung Chow Chan, Herman Lam, Y C Lee, and Xue-Ming Zhang ISBN 0-471-25953-5 Copyright  2004 John Wiley & Sons, Inc 11 12 POTENCY METHOD VALIDATION Method development Method validation/ revalidation QC laboratory Figure 2.1 Life cycle of an analytical method of the drug substance and drug product, this validated method may need to be... biological procedures This chapter focuses on validation of the potency assay by high -performance liquid chromatography (HPLC) Analytical method development and validation involve a series of activities that are ongoing during the life cycle of a drug product and drug substance Figure 2.1 summarizes the life cycle of an analytical method Analytical potency method development should be performed to the... information for validation of common analytical methods (e.g., potency, related substances, and dissolution testing) Method validation for pharmaceutical excipients, heavy metals, and bioanalysis are discussed in Chapters 6 to 8 The instrument performance verification section of the book provides unbiased information on the principles involved in verifying the performance of instruments that are used for the... personnel, and users of equipment, hardware, and software through the entire qualification and validation process, from writing specifications and vendor qualification to installation and to both initial and ongoing operations Chapter 18 is an in-depth discussion of the approaches to validation of Excel spreadsheets, one of the most commonly used computer programs for automatic or semiautomatic calculation and. .. Drug Products Early methods to support synthetic and formulation developments are often developed in the form of potency assay, impurities/related substance assay, dissolution, Karl Fischer, identity, chiral method, and content uniformity These analytical methods are developed and validated in a fast and timely manner to support all phase II studies Common Studies Performed on the API and Drug Product... Calibration & Validation Group (CVG) in Canada, I have set up a technical solution-sharing page at the Web site www.cvg.ca The third pillar, training, is best left to individual organizations, as it will be individualized according to each organization’s strategy and culture The method validation section of this book discusses and provides guidance for the validation of common and not-so-common analytical methods... considered as the culmination of a three-pronged approach to data generation and management: method validation, calibrated instrument, and training The requirement for the generation of reliable data is very clearly represented in the front cover design, where the three strong pillars represent method validation, calibrated instrument, and training, respectively This book is designed to cover two of the three... reporting of standard deviation, relative standard deviation (coefficient of variation), and confidence interval of the data Reproducibility Reproducibility measures the precision between laboratories as in collaborative studies This parameter should be considered in the standardization of an analytical procedure (e.g., inclusion of procedures in pharmacopoeias 20 POTENCY METHOD VALIDATION and method transfer... standard stability performed on an analytical procedure The two sets of data indicate that the sample and standard Table 2.4 Results from Method Transfer between Two Laboratories Runs Originating laboratory Receiving laboratory Average % 12 100.7 4 100.2 STRATEGIES AND VALIDATION PARAMETERS 21 Table 2.5 Stability of Sample and Standard Solutions Day % Initial Sample Standard 1 2 3 4 100.2 100.0 99.9 —... COMMON PROBLEMS AND SOLUTIONS 23 2.6 COMMON PROBLEMS AND SOLUTIONS In the following pages we summarize some of the common deficiencies of potency method validation These common problems are grouped together into categories such as HPLC instrumentation, procedural steps, and miscellaneous errors 2.6.1 HPLC Instrumentation Errors Qualification of Instruments The status of the qualification of HPLC and other equipment . WILEY & SONS, INC., PUBLICATION ANALYTICAL METHOD VALIDATION AND INSTRUMENT PERFORMANCE VERIFICATION ANALYTICAL METHOD VALIDATION AND INSTRUMENT PERFORMANCE VERIFICATION Edited by CHUNG CHOW. the accuracy and integrity of this document Date: 2005.04.26 20:58:03 +08'00'