Analytical Method Validation

There has been increased regulatory scrutiny on validation of analytical methods. PSC can assist you in the validation of analytical methods to meet ICH standards. We can also support you in the validation of test methods required for your stability studies and cleaning validation studies. Our experts will help you to identify the relevant validation requirements.

Code of Federal Regulations (CFR) 311.165c states that “the accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented.”. This means that the method used in laboratories should not only be reviewed but tested so they comply with the regulatory specifications. We will help your company develop methods that you can use to test your product to be of consistent quality from development to production. With PSC, your test methods will be accurate, precise, specific, robust, able to detect parameters, able to quantify parameters, linear, and have a defined range.