SMS Pharmaceuticals Quality Control Reviewer Interview Questions and Answers

Analytical method validation is the process of demonstrating that an analytical procedure is suitable for its intended use.

• It involves evaluating the performance characteristics of the method, such as accuracy, precision, specificity, and linearity.

• Validation ensures that the method is reliable and produces accurate results consistently.

• Parameters validated include system suitability, method robustness, and stability.

• E...read more

Method validation ensures the method is suitable for its intended use, while method verification confirms the method performs as expected.

• Method validation is performed during the development of a new method to ensure it is suitable for its intended use.

• Method verification is performed to confirm that an established method performs as expected in the user's laboratory.

• Validation involves testing the method's accuracy, ...read more