Answer»
- Analytical method VALIDATION is the documented process of ensuring a pharmaceutical analytical method is suitable for its intended use.
- This is achieved by performing a series of experiments on the procedure, materials, and equipment that comprise the method being validated. The experimental results undergo STATISTICAL analysis, and a series of pre-defined acceptance criteria are APPLIED to the results.
- Establishing that the analytical method consistently produces reliable analytical results is a critical element of assuring the quality and safety of pharmaceutical products.
- A validated analytical method is one has been documented as selective, accurate, precise, and linear over a stated range. Additional parameters and performance characteristics are often evaluated for methods of greater complexity. These serve to establish the method ruggedness vs robustness.
- Analytical method validation is a requirement for entities engaging in the testing of biological samples and pharmaceutical products for the purpose of drug exploration, development, and manufacture for human use. It also of great VALUE for any TYPE of routine testing that requires consistency and accuracy.
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