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Analytical Method Validation - cdn.intechweb.org
1 Analytical Method Validation Pedro Lopez Garcia1, Ernesto Buffoni1, Fabio Pereira Gomes1 and Jose Luis Vilchez Quero2 1 Instituto de Aperfei oamento Farmac utico (IAF) 2 Department of Analytical Chemistry, Faculty of Sciences, University of Granada 1 Brazil 2 Spain 1. Introduction In pharmaceutical industries, the Validation of Analytical methods is used to demonstrate that the Method is fitted for its purpose; it must follow a plan which includes scope, performance characteristics, and acceptance limits. Analytical methods need to be validated or revalidated prior to their introduction into routine analyses (release of batch). The overarching philosophy in current good manufacturing practices (cGMPs) of the twenty - first century and robust modern quality systems is the quality that it has to be built into the product, and testing alone cannot be relied to ensure the quality of the product.
Analytical Method Validation 5 analytical procedures is equall y important to those listed herein, and it may be addressed in subsequent documents.
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Tests, Robustness, Ruggedness, Method, VALIDATION, Using Plackett Burman partial factorial designs, Method robustness, Validation of Alternative Microbiological Methods, Global Conference on Pharmaceutical Microbiology, Validation of Titration Methods, Method Validation, Validation of Compendial, Robust, INTERNATIONAL RESEARCH JOURNAL OF PHARMACY