Validation of the analytical method serves as a confirmation through testing and formal presentation of documented evidence that the analytical method is suitable for the intended aim and enables trustworthy results.
The transfer of the analytical method constitutes the process of recreating the method in another lab, which gives certainty that the analytical method is the same in both labs and that it has been transferred in the correct manner. If the transfer of method to the new lab is properly carried out, there is no need to perform method validation in receiving lab.
We offer the possibility to carry out validations of methods prepared by us and those that have been provided to us by our customers. Validations are carried out in accordance with the international requirements regarding validation of analytical methods, including the ICH Q2(R1) guideline and internal procedures and / or in accordance with the procedures of the customer.
The scope of validation is always agreed on in detail with the customer and after the validation has come to an end the customer receives a final report.
At the request of the customer we also perform the transfer of the validated method to another lab.
Our professionals can help define the scope of work relating to the transfer, identify the critical methods and create the transfer documentation.
The transfer itself is carried out in accordance with internal procedures or the procedures of the customer.
We also perform verification (transfer) of pharmacopoeial methods.