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Step-by-Step Analytical Methods Validation and Protocol in ...
Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry BY GHULAM A. SHABIR.. Introduction peatability and intermediate precision), specificity, detec- Methods Validation : Establishing documented evidence tion limit, quantitation limit, linearity, range, and robustness that provides a high degree of assurance that a specific (Figure 1). In addition, Methods Validation information method, and the ancillary instruments included in the should also include stability of Analytical solutions and sys- 7. method, will consistently yield results that accurately reflect tem suitability. the quality characteristics of the product tested. Health Canada (HC) has also issued guidance on meth- 8. Method Validation is an important requirement for any ods Validation entitled Acceptable Methods Guidance. HC. package of information submitted to international regula- has been an observer of ICH, and has adopted ICH guide- tory agencies in support of new product marketing or clini- lines subsequent to its reaching Step Four of the ICH.
acceptance criteria of a validation protocol. This paper is a step-by-step practical guide for preparing protocols and per-Ghulam A. Shabir Validation Assay Testing for Impurities Identification Characteristics Accuracy Yes Yes No No Precision - Repeatability Yes Yes No No Precision - Intermediate Yes1 Yes* No No Precision
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