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PHARM 462

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PHARM 462

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    1. PHARM 462 1 2009

    2. European and International regulatory bodies and their guidelines on different aspects of QA 2 2009

    3. Method Validation Validation of analytical procedures is the process of determining the suitability of a given methodology for providing useful analytical data. J. Guerra, Pharm. Tech. March 1986 Validation is the formal and systematic proof that a method compiles with the requirements for testing a product when observing a defined procedures. G. Maldener, Chromatographia, July 1989 3 2009

    4. Method validation is the process of demonstrating that analytical procedures are suitable for their intended use and that they support the identity, strength, quality, purity and potency of the drug substances and drug products Method validation is primarily concerned with: identification of the sources of potential errors quantification of the potential errors in the method An method validation describes in mathematical and quantifiable terms the performance characteristics of an assay 4

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