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Step 1: Method Evaluation and Further Method Development. Step 2: Final Method Development and Trial Method Validation. Step 3: Formal Method Validation and Report Generation.
The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications.
This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well.
All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation.
It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations.