Validation is the process of proving that an analytical method can accurately and reproducibly measure the intended target, and the validation approach should be tailored to demonstrate that the method is suitable under actual conditions of use. This process is just good science and gives assurance that the data has a high degree of reliability.
When testing regulated products such as Pharmaceuticals, Medical Devices, Dietary Supplements or even Cosmetics, the method will be used to determine the quality attributes of the product. Thus, the validation approach becomes critically important to supporting the overall Quality by Design (QbD) principles Thus, there is heighten scrutiny by domestic and international regulatory authorities to the validation approach. Failure to adequately validate the methods can result in non-approval of the product or product recalls.
We have several years of experience in validating analytical methods in diverse settings, including pharmaceutical, environmental and foods.